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Naltrexone Hydrochloride, USP (Anhydrous)

Naltrexone Hydrochloride, USP (Anhydrous)

CAS: 16676-29-2

 

Naltrexone Hydrochloride USP (Anhydrous) is a white to almost white powder that is very hygroscopic. Naltrexone Hydrochloride is very soluble in water and slightly soluble in alcohol. The limit of total solvents can be up to 5% for the anhydrous version.

 

Alternative name(s): Naltrexone hydrochloride anhydrous

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1. What is the difference between Naltrexone Hydrochloride (Anhydrous) and Naltrexone Hydrochloride (Dihydrate)?

  • Water and solvent content. The total content may be up to 5% for the anhydrous version, and up to 11% for the dehydrate version.
  • For compounding purposes, both can be used and calculated the same way for potency.
  • As there are lot-to-lot variation, it is important that the COA be referenced to verify the percentage of the solvent content and the assay for either version used.

2. How do you calculate for capsule form? 

The Limit of Total Solvents can be up to 5% for the anhydrous form and up to 11% for the dihydrate form. For compounding purposes, either form can be used and, in both cases, calculations to determine the potency of Naltrexone Hydrochloride should be performed using the Total Solvent Content and the Assay on Anhydrous, Solvent-free Basis. As there are lot-to-lot variation of the Total Solvent Content and the Assay on Anhydrous, Solvent-free Basis, it is important that the Certificate of Analysis be referenced to verify the results (in %) of these tests. Refer to sample formula F 009 673 for guidance.