Hetastarch in Sodium Chloride 6 g/100mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Plasma Volume Expander class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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0.9 g / 100 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hextend 6 g/100mL 00409-1555-54 | Hospira, | 500 ml | — | — | FDA listed | — |
| Hetastarch in Sodium Chloride 6 g/100mLthis 00409-7248-03 | Hospira, | 500 ml | — | — | FDA listed | — |
| 6% Hetastarch In 0.9% Sodium Chloride 6 g/100mL 51662-1317-01 | HF | 500 ml | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00409-7248-03 You're viewing this | 12 CONTAINER in 1 CASE (0409-7248-03) / 500 mL in 1 CONTAINER (0409-7248-13) | 2005-02-28 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. ( 1 ) WARNING: MORTALITY; KIDNEY INJURY; COAGULOPATHY See full prescribing information for complete boxed warning. • Use of hydroxyethyl starch (HES) products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, increases risk of o Mortality o Kidney injury ( 5.1 ) o Coagulopathy ( 5.2 ) • DO NOT use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.
( 1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 6% Hetastarch in 0.9% Sodium Chloride Injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable. It is not a substitute for blood or plasma. The adjunctive use of 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. • 6% Hetastarch in 0.9% Sodium Chloride Injection is a hetastarch indicated for treatment of hypovolemia when plasma volume expansion is desired in settings where adequate alternative treatment is unavailable.
( 1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection in leukapheresis has shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosage for Acute Use in Plasma Volume Expansion 6% Hetastarch in 0.9% Sodium Chloride Injection is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration. For intravenous use only.
Recommended Dosage Dose Adults ( 2.1 ) 500 to 1000 mL Leukapheresis ( 2.2 ) 250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is added to the input line of the centrifugation apparatus.
2.1Adults The amount usually administered is 500 to 1000 mL. Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required. Higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred [see Warnings and Precautions (5) ].
2.2Leukapheresis 250 to 700 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection with citrate anticoagulant is administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The 6% Hetastarch in 0.9% Sodium Chloride Injection and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.
2.3Direction for use for 6% Hetastarch in 0.9% Sodium Chloride Injection • Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting.
Such handling could result in breakage of the container. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use only if solution is clear and container and seals are intact. • Intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. • Withdraw or expel all air from the bag through the medication port prior to infusion if administration is by pressure infusion. • For single use only.
The solution contains no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and is intended only for single-dose injection. When smaller doses are required the unused portion should be discarded. CAUTION: Before administering to the patient, review these directions: Visual Inspection • Do not remove the plastic infusion container from its overwrap until immediately before use. • Inspect each container.
Read the label. Ensure solution is the one ordered and is within the expiration date. • Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. • Any container which is suspect should not be used. To Open 1.
Tear overwrap down at notch and remove solution container. 2. Check for minute leaks by squeezing solution container firmly.
3. If any leaks are found, discard solution as sterility may be impaired. Preparation for Administration 1.
Remove plastic protector from sterile set port at bottom of container. 2. Attach administration set.
Refer to complete directions accompanying set. When stored at room temperature, 6% Hetastarch in 0.9% Sodium Chloride Injection admixtures of 500–560 mL with citrate concentrations up to 2.5% were compatible for 24 hours. The safety and compatibility of additives other than citrate have not been established.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Single-dose container: • 30 g hetastarch in 500 mL of 0.9% sodium chloride injection. • 30 g hetastarch in 500 mL 0.9% sodium chloride injection. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable. • Do not use HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection, unless adequate alternative treatment is unavailable.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Avoid use in patients with pre-existing renal dysfunction ( 5.1 ) • Increased risk of mortality and acute kidney injury (AKI) in critically ill patients, including patients with sepsis; surgical patients; and blunt trauma patients ( 5.1 ) • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury ( 5.1 ) • Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection ( 5.1 ) • 6% Hetastarch in 0.9% Sodium Chloride Injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired.
Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy ( 5.2 ) • Monitor liver function in patients receiving HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection ( 5.2 )
5.1Mortality and Renal Dysfunction • Critically ill patients, including patients with sepsis, are at increased risk of mortality and acute kidney injury (AKI), including need for renal replacement therapy (RRT) • Surgery patients are at increased risk of mortality and AKI • Blunt trauma patients are at increased risk of mortality and AKI • Avoid use in patients with pre-existing renal dysfunction • Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at the first sign of renal injury • Continue to monitor renal function for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including 6% Hetastarch in 0.9% Sodium Chloride Injection
5.2Coagulopathy • 6% Hetastarch in 0.9% Sodium Chloride Injection is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired. Monitor the coagulation status of surgery patients, as excess bleeding has been reported with HES solutions in this population. Discontinue use of 6% Hetastarch in 0.9% Sodium Chloride Injection at first sign of coagulopathy 1–2 6% Hetastarch in 0.9% Sodium Chloride Injection has not been adequately evaluated to establish its safety in uses over extended periods other than leukapheresis.
6% Hetastarch in 0.9% Sodium Chloride Injection has been associated with coagulation abnormalities in conjunction with an acquired, reversible von Willebrand's-like syndrome and/or Factor VIII deficiency when used over a period of days. Replacement therapy should be considered if a severe Factor VIII deficiency is identified. If a coagulopathy develops, it may take several days to resolve.
Certain conditions may affect the safe use of 6% Hetastarch in 0.9% Sodium Chloride Injection on a chronic basis. For example, in patients with subarachnoid hemorrhage where 6% Hetastarch in 0.9% Sodium Chloride Injection is used repeatedly over a period of days for the prevention of cerebral vasospasm, significant clinical bleeding may occur. Intracranial bleeding resulting in death has been reported.
3 Slight declines in platelet counts and hemoglobin levels have been observed in donors undergoing repeated leukapheresis procedures using 6% Hetastarch in 0.9% Sodium Chloride Injection due to the volume expanding effects of hetastarch and to the collection of platelets and erythrocytes. Hemoglobin levels usually return to normal within 24 hours. Hemodilution by 6% Hetastarch in 0.9% Sodium Chloride Injection may also result in 24 hour declines of total protein, albumin, calcium, and fibrinogen levels.
Regular and frequent clinical evaluation and complete blo…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Serious adverse reactions reported in postmarket clinical trials include increased mortality and AKI (including need for RRT) in critically ill subjects, including subjects with sepsis, and surgical subjects. Clinical trials have also shown increased mortality and AKI in blunt trauma subjects. Increased coagulopathy was reported in surgical subjects.
Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. • Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. (Note: All of the studies listed below used licensed HES products except for reference 4.) A randomized controlled trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17; 95% CI, 1.01 to 1.36; p=0.03) and RRT (relative risk, 1.35; 95% CI, 1.01 to 1.80; p=0.04) in the HES treatment arm.
4 Another randomized controlled trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk, 1.20; 95% CI, 0.83 to 1.74; p=0.33) and a trend for RRT (relative risk, 1.83; 95% CI, 0.93 to 3.59; p=0.06) in HES patients. 5 A randomized controlled trial (N=7000) using different HES in a heterogeneous patient population consisting of critically ill adult patients admitted to the ICU reported no difference in mortality (relative risk, 1.06; 95% CI, 0.96 to 1.18; p=0.26) but increased use of RRT (relative risk, 1.21; 95% CI, 1.00 to 1.45; p=0.04) in HES patients.
6 In a retrospective study of adult patients (N=1442) undergoing pulmonary or esophageal surgery who were prophylactically fluid restricted during the procedure, 74 developed AKI (5.1%) within the first 72 hours postoperatively. Fluid restriction neither increased nor was a risk factor for AKI. AKI occurred more often when HES products were administered to patients with decreased renal function or having >2 risk factors with normal renal function, whereas restriction of crystalloid was unrelated to AKI, regardless of preoperative renal function.
12 In a retrospective case series of high-risk adult vascular surgery patients (N=796) receiving fluid therapy during a vascular surgery procedure, logistic regression analysis using prespecified confounding variables or suspected risk factors for AKI showed that intraoperative administration of an HES product was associated with increased likelihood of 30-day mortality and need for RRT, compared with use of crystalloids alone. 13 In a retrospective study of adult subjects undergoing elective noncardiac surgery, patients (N=14,680) receiving an HES product and crystalloid were propensity-matched with patients (N=14,680) receiving only crystalloid.
After controlling for potential confounding variables, odds of experiencing AKI of severe intensity with HES was 21% greater than with crystalloid alone. In addition, AKI risk increased as a function of HES volume. 14 In a prospective observational study assessing the impact of HES products on recipient renal graft outcomes in brain-dead organ donors, data were obtained on 986 kidneys transplanted from 529 donors.
Kidneys from donors who received HES had a higher rate of delayed graft function in recipient subjects (41% versus 31%). After accounting for the propensity of donors to receive HES products, HES product administration was independently associated with an increased risk of delayed graft function in recipients. A dose response relatio…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 6% Hetastarch in 0.9% Sodium Chloride Injection should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system. • The safety and compatibility of other additives have not been established. • Use with caution with drugs that negatively influence the coagulation system. ( 7 ) • The safety and compatibility of other additives have not been established. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.
There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.3Nursing Mothers It is not known whether hetastarch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 6% Hetastarch in 0.9% Sodium Chloride Injection is administered to a nursing woman.
8.4Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.
🤰 Pregnancy ▾
8.1Pregnancy Hetastarch has been shown to have an embryocidal effect on New Zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 mL) and on BD rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. When hetastarch was administered to New Zealand rabbits, BD rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident.
There are no adequate and well-controlled studies in pregnant women. 6% Hetastarch in 0.9% Sodium Chloride Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of hetastarch in pediatric patients have not been established. Adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% Hetastarch in 0.9% Sodium Chloride Injection in pediatric patients have not been conducted.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.
12.2Pharmacodynamics 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume that decreases over the succeeding 24 to 36 hours. The degree of plasma volume expansion and improvement in hemodynamic state depend upon the patient's intravascular status.
12.3Pharmacokinetics Hetastarch molecules below 50,000 molecular weight are rapidly eliminated by renal excretion. A single dose of approximately 500 mL of 6% Hetastarch in 0.9% Sodium Chloride Injection (approximately 30 g) results in elimination in the urine of approximately 33% of the dose within 24 hours. This is a variable process but generally results in an intravascular hetastarch concentration of less than 10% of the total dose injected by two weeks.
A study of the biliary excretion of 6% Hetastarch in 0.9% Sodium Chloride Injection in 10 healthy males accounted for less than 1% of the dose over a 14 day period. The hydroxyethyl group is not cleaved by the body but remains intact and attached to glucose units when excreted. Significant quantities of glucose are not produced as hydroxyethylation prevents complete metabolism of the smaller polymers.
The addition of hetastarch to whole blood increases the erythrocyte sedimentation rate. Therefore, 6% Hetastarch in 0.9% Sodium Chloride Injection is used to improve the efficiency of granulocyte collection by centrifugal means.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The plasma volume expansion produced by 6% Hetastarch in 0.9% Sodium Chloride Injection approximates that of 5% Albumin (Human). Intravenous infusion of 6% Hetastarch in 0.9% Sodium Chloride Injection results in expansion of plasma volume.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 6% Hetastarch in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in 500 mL single-dose flexible plastic containers. Unit of Sale Concentration NDC 0409-7248-03 Case containing 12 Flexible Plastic Containers 30 g Hetastarch/500 mL (6 g Hetastarch/100 mL) Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1287-6.0 Hospira logo
📋 Description ▾
11 DESCRIPTION 6% Hetastarch in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution for intravenous administration. Each 100 mL contains: Hetastarch............................................................................ 6 g Sodium Chloride, USP........................................................
0.9g Water for Injection, USP..................................................... qs pH adjusted with Sodium Hydroxide, NF if necessary Concentration of Electrolytes (mEq/L): Sodium (Na + ) 154, Chloride (Cl - ) 154 (not including ions for pH adjustment). pH: 5.5 (3.5 to 7.0) Total osmolar concentration is 308 mOsmol/liter (calc). Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent.
The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 670,000 with a range of 550,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,500,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6.
The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by α-1,4 linkages with occasional α-1,6 branching linkages. The degree of branching is approximately 1:20 which means that there is one 1–6 branch for every 20 glucose monomer units. The chemical name for hetastarch is hydroxyethyl starch.
The structural formula is as follows: Amylopectin derivative in which R 2 , R 3 , and R 6 are H or CH 2 CH 2 OH, or R 6 is a branching point in the starch polymer connected through a 1-6 linkage to additional alpha-D-glucopyranosyl units. Hetastarch is an artificial colloid pharmacologically classified as a plasma volume expander; 0.9% Sodium Chloride Injection is a fluid and electrolyte replenisher. 6% Hetastarch in 0.9% Sodium Chloride Injection is a clear, pale yellow to amber solution.
Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident. The flexible plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content.
Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula hetastarch