Not every manufacturer has the resources, expertise, or equipment available to conduct raw materials testing and interpret the results. At RSSL, we have expertise to apply pharmacopoeia monographs, transferring in methods, or developing new methods on client’s behalf. We also provide GMP QC testing services for your APIs, excipients and drug products which is what our client required.

During QC testing, our team within the Wet Chemistry laboratory discovered that some of the batches of Ammonium Sulphate contained high levels of Nitrates and did not meet the acceptance criteria for the Limit of Nitrates to USP pharmacopoeia. Nitrates, which is an impurity from the manufacturing of Ammonium Sulphate, can be reduced to Nitrites by bacteria cultures that naturally occur in the human body. The high level of Nitrates provided a problem as Nitrites are one of the precursors for Nitrosamines formation which are compounds known for their toxicity.