The carrier gas is nitrogen or helium with a linear velocity of about 35 cm per second and a split ratio of 1: The injection port and detector temperatures are maintained at andrespectively. For the Class 1 solvents other than 1,1,1-trichloroethane, prepare the first dilution as directed for the first dilution under Class 1 Standard Stock Solution in Procedure A. The carrier gas is nitrogen or helium with a linear velocity of about 35 cm per second, and a split ratio of 1:
The purpose of the chapter is to limit the amount of solvent that patients receive. This language is not specific to dermatological and topical products. Protein manufacturers do not use solvents in their manufacturing processes.
The chapter states that no testing is required if you know that solvents are not present. However, it is always prudent to evaluate your starting materials and finished product.
Is it possible that USP will consider setting standards for residual solvents in packaging components? Residual solvents in packaging are not addressed by this chapter. We are aware of extractables and leechables, and we may consider this aspect in the future. ICH Q3C does not apply to existing commercial drug product.
Please confirm that the USP requirement applies to all existing commercial drug products. Are manufacturers of finished products required to test the active ingredient and the excipients? If we use Water for Injection for dilution of drug substances to make drug products, do we need to test Water for Injection for residual solvents?
Will the chapter apply to veterinary products in the future? However, the current limits are based on human use and limits for different species of animals probably would need to be different. Q3C does not address the issue of raw materials used in an API. The bottom line is to assure the material that is going out to patients does not harm them.
If you do option 1, this test takes care of the solvent issues for these materials. Do we need to confirm that no solvent contamination occurs during packaging or repackaging? The chapter covers only those solvents used in the manufacturing process.
Accidental contamination during packaging, handling, or shipping should be managed through good handling and shipping practices.
False Vendor Materials True Do we need to perform a complete residual solvent analysis to verify the information provided by our vendor? It is up to the manufacturer to determine whether or not to test.
The decision may depend on the confidence and the relationship between the manufacturer and supplier. The manufacturer may choose to audit the vendor. If an excipient manufacturer states that class 2 solvents are present in their excipient, but below the option 1 limit, does the drug product manufacturer have to test for these solvents?
Use good science and prudent behavior in a GMP environment to demonstrate the absence of solvent. Could the USP make changes to the method in the future?Oct 14, · is there any usp(or any pharmacopoeia) method available for determination of class 3 residual solvents (acetone 2-propanol.),using head space-GC.
or any validated method is available for determining class 3 residual solvents using head space-GC. Residual Solvents Mixture - Class IIA Pharmaceutical Secondary Standard; Certified Reference Material; find Sigma-Aldrich-PHR MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich.
The USP general chapter Residual Solvents is a widely used compendial method used for identifying and quantifying residual solvents when there is no information available on what solvents are likely to be present.
The objective of this general chapter is to provide acceptable amounts of residual solvents in pharmaceuticals for the safety of the patient. The general chapter recommends the use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.
Analytical method transfers are certainly among the most discussed topics in the GMP regulated sector. However, they are surprisingly little regulated in detail.
tion describes analytical methods for performing RS testing. Limits and different methods for determina-tion of RS have been finally integrated in USP (1). Methods accepted by pharmacopoeias and ICH guidelines The first analytical method for RS, which was published in pharmacopoeias, was a .