Enoxaparin Sodium is recognized in the United States Pharmacopeia (USP) with specific monographs detailing its quality standards. The USP monograph for Enoxaparin Sodium specifies that it is the sodium salt of a depolymerized heparin, obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. The monograph outlines that Enoxaparin Sodium should have a potency of not less than 90 and not more than 125 Anti-Factor Xa International Units (IU) per milligram, and not less than 20.0 and not more than 35.0 Anti-Factor IIa IU per milligram, calculated on the dried basis. The ratio of Anti-Factor Xa activity to Anti-Factor IIa activity is specified to be between 3.3 and 5.3. Additionally, the weight-average molecular weight is defined as 4500 Da, with specific percentage ranges for molecular weights below 2000 Da, between 2000 and 8000 Da, and above 8000 Da. These standards ensure the consistency, purity, and efficacy of Enoxaparin Sodium used in therapeutic applications.
Regarding dissolution and stability testing, Enoxaparin Sodium Injection is required to be a sterile solution of Enoxaparin Sodium in Water for Injection, with its appearance analyzed for clarity and degree of color using a validated method. The potency value should be not less than 90% and not more than 110% of the potency stated on the label in terms of International Anti-Factor Xa Units (IU). Stability testing should be conducted in accordance with the International Council for Harmonisation (ICH) guidelines, considering the climatic zone of the intended market to ensure the product maintains its quality throughout its shelf life.
It is important to note that while the USP provides comprehensive standards for Enoxaparin Sodium, similar monographs and standards are likely present in other major pharmacopoeias such as the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These pharmacopoeias may have specific requirements and testing protocols to ensure the quality and efficacy of Enoxaparin Sodium in their respective regions.
