METHOD OF PREPARATION
Note: This formulation should be prepared in a laminar airflow hood in a cleanroom or via isolation barrier technology by a validated aseptic compounding pharmacist using strict aseptic technique. This is a high-risk preparation.1
1. Calculate the required quantity of each ingredient for the total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Dissolve the meperidine hydrochloride and atropine sulfate in about 95 mL of sterile water for injection.
4. Add sufficient sterile water for injection to volume and mix well.
5. Filter through an appropriate sterile 0.22-pm filter into a suitable sterile, single-use container (vial, syringe).
6. Package and label.
Package in sterile containers.1
Keep out of reach of children. Use only as directed. For professional use only.
If not sterility tested: A beyond-use date of up to 24 hours at room temperature, up to 3 days at refrigerated temperature (2° to 8°C), or up to 45 days if frozen can be used for this preparation.
If sterility tested: A beyond-use date of up to 14 days stored in a refrigerator can be used for this preparation.1
Meperidine hydrochloride/atropine sulfate injection is used in the treatment of severe pain.
Quality-control assessment can include weight/volume, physical observation, pH, specific gravity, osmolality, assay, color, clarity, paniculate matter, sterility, and pyrogenicity.2,3
The endotoxin unit (EU) maximum would be 12,000 for 5,000 mg of meperidine hydrochloride. The EU maximum would be 2,224 for 40 mg of atropine sulfate. The total maximum endotoxin level would be 12,000 + 2,224 = 14,224 EU for the 100 mL, or 142.24 EU per milliliter.
Meperidine hydrochloride (C^sub 15^H^sub 21^NO^sub 2^.HCl, MW 283.79, isonipecaine hydrochloride, pethidine hydrochloride) occurs as a fine, white crystalline, odorless powder. Meperidine hydrochloride is very soluble in water and soluble in alcohol. It melts between 186° and 189°C and should be preserved in well-closed, lightresistant containers. A solution of 5 g in 100 mL of water has a pH of about 5. Meperidine hydrochloride injection has a pH of 3.5 to 6.0 and a maximum endotoxin limit of not more than 2.4 EU per milligram of meperidine hydrochloride. Meperidine hydrochloride is used in the management of moderate to severe pain and as an adjunct to anesthesia and preoperative sedation.4
Atropine sulfate [(C^sub 17^H^sub 23^NO^sub 3^)^sub 2^.H^sub 2^SO^sub 4^.H^sub 2^O, MW 694.33] occurs as colorless crystals, or as a white, crystalline powder. It is odorless and effloresces in dry air. It is slowly affected by light. It is very soluble in water and freely soluble in alcohol and glycerin. It should be preserved in tight containers. Atropine sulfate injection contains not more than 55.6 EU per milligram of atropine sulfate.1
Sterile water for injection is water for injection that has been sterilized and suitably packaged; it contains no added substance. Water for injection is water purified by distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms. It is prepared from water that complies with the U.S. Environmental Protection Agency National Primary Drinking Water Regulations or comparable regulations of the European Union or Japan. It contains no added substance.4
1. United States Pharmacopeial Convention, Inc. United States Pharmacopeia 28-National Formulary 23. Rockville, MD: US Pharmacopeial Convention, Inc.; 2004: 200-201, 1208, 2345-2349, 2457-2477, 2878, 2901.
2. Allen LV Jr. Standard operating procedure for participate testing for sterile products. IJPC 1998; 2(1): 78.
3. Allen LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC 1998; 3(5): 406-407.
4. Ellison A, Nash RA, Wilkin MJ. Water. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 672-676.
Copyright International Journal of Pharmaceutical Compounding Sep/Oct 2005
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