Question: My Benzoyl Peroxide label says it is 70% Benzoyl Peroxide but it is "Hydrous Benzoyl Peroxide USP." I need to make 100 mL of a Benzoyl Peroxide 10% Lotion; how much do I use?

Answer: In this case, the "Hydrous Benzoyl Peroxide USP" is defined as containing NLT 90.0% and NMT 110.0% of the labeled amount of C₁₄H₁₀O₄. It contains a minimum of 20% water for the purpose of reducing flammability and shock sensitivity.

It also has a precautionary statement, as follows:

[Caution-Hydrous benzoyl Peroxide may explode at temperatures higher than 60�C or cause fires in the presence of reducing substances. Store it in the original container, treated to reduce static charges.]

Looking at Official Products in the USP:

Benzoyl Peroxide Gel USP contains NLT 90.0% and NMT 125% of the labeled amount of benzoyl peroxide (C₁₄H₁₀O₄).

Benzoyl Peroxide Lotion USP contains NLT 90.0% and NMT 110.0% of the labeled amount of benzoyl peroxide (C₁₄H₁₀O₄).

It is evident that the products contain the specified percentages of the actual chemical benzoyl peroxide (C₁₄H₁₀O₄).

In addressing the need for 100 mL of a 10% Benzoyl Peroxide lotion, one would need 10 g of Benzoyl Peroxide, C₁₄H₁₀O₄:

70/100 = 10 g/x g

X = 14.286 g of Hydrous Benzoyl Peroxide USP for the preparation to provide 10 g of C₁₄H₁₀O₄.

It is important to refer to the label and the Certificate of Analysis for the specific Lot of the Benzoyl Peroxide to confirm the actual concentration of Benzoyl Peroxide in the bulk material and adjust accordingly.

Please note that this is not always the case in calculating the actual quantity of API to use, as it depends upon the API and the USP-NF monographs and commercial products, which we will discuss in the future.

Please address any questions to the following email address: lallen@ijpc.com

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Five Convicted in Meningitis Outbreak Case
Four former employees and an owner of the Massachusetts facility responsible for a nationwide fungal meningitis outbreak that killed over 100 people and sickened hundreds were convicted Thursday of fraud and other offenses. A Boston jury acquitted another employee of all charges after several days of deliberations. The defendants were among 14 people charged in 2014 following an investigation into the outbreak, which sickened almost 800 people. The CDC put the death toll at 64 as of October 2013. Federal prosecutors say more than 100 people have now died.
https://www.apnews.com/1939566088af4302b6479b13caf61c39

Another Pharmacy Compounding Accreditation/Certification Program
Healthcare Facilities Accreditation Program (HFAP) is launching a Compounding Pharmacy Certification program for pharmacies to demonstrate their commitment to excellence and quality control. Attention to detail is key in compounding, as the smallest of errors can lead to devastating consequences for patient health and safety. To ensure these preparations are successful, compounding pharmacies must establish a risk-management protocol that keeps patient safety and quality of services top-of-mind.
https://www.drugstorenews.com/pharmacy/hfap-unveils-compounding-pharmacy-certification/

Pfizer Still Has Problems with Hospira Injectables
Since last year when Pfizer's Kansas plant received an FDA warning letter, the company has insisted it is making good progress on turning things around at the essential but troubled injectables facility. However, the findings from the most recent inspection show that not only do problems persist, but most of them had been flagged previously by the FDA.
https://www.fiercepharma.com/manufacturing/issues-persist-at-pfizer-s-hospira-injectables-plant

Putting Profits Ahead of Safety: China's Zhejiang Huahai Lambasted in an FDA Warning Letter
The FDA has stated that when Zhejiang Huahai Pharmaceutical altered its manufacturing process in 2011 to include a solvent suspected of producing an impurity, it didn't even consider that the changes might lead to the formation of mutagenic impurities in its valsartan APIs. "You failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process," the warning letter says. That criticism of the Chuannan plant comes despite the fact that the FDA has admitted that it was unaware that certain manufacturing processes under certain conditions would result in the formation of N-nitrosodiethylamine and N-nitrosodimethylamine during manufacturing of "sartan" products. The two probable carcinogens were discovered in valsartan APIs produced by Huahai but have since been found in the APIs of other drugmakers, including Aurobindo and Mylan, and in finished products from Sandoz and Teva.
https://www.fiercepharma.com/manufacturing/china-s-zhejiang-huahai-lambasted-fda-warning-letter-for-putting-profits-ahead-safety

Did You Know ...

�that Walt Disney said the following?

The important thing is the family. If you can keep the family together - and that's the backbone of our whole business, catering to families - that's what we hope to do.

Walt Disney also said:

Our greatest natural resource is the minds of our children.

Tip of the Week

There are many forces shaping our children today, including television, radio, music, movies, iPhones, texting, peers, ministers, and parents. Many can be negative and some can be positive. Which of these has the greatest influence?

The future of our nation depends upon parents raising their children properly.

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Looking Back

From Saskatoon
To Alabam'
You hear men praise,
The shave what am!
     Burma Shave