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Add 1 mL bacteriostatic water using a fresh insulin syringe inserted at a 45-degree angle against the vial glass wall (not directly onto the powder)

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Quality assurance was taken for sterility by testing 20% of the final lot, using USP 71 guidelines for sterility testing, 57 USP 85 endotoxin testing, 58 and USP 1116 for environmental testing 59 following all cGMP standards and ISO 5 conditions