Pharma Stability: Insights, Guidelines, and Expertise
Photostability Testing Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for conducting photostability studies on drug substances and drug products. This ensures that the products are tested under controlled light conditions to determine their stability when exposed to light. Scope This SOP applies to all drug substances and…
Photostability Chamber operation Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of photostability chambers used in stability studies. This ensures that the chambers are used correctly to provide accurate and reliable photostability data. Scope This SOP applies to all personnel operating photostability chambers for…
Photostability Chamber Calibration Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of photostability chambers. Proper calibration ensures that the chambers provide accurate and reliable light intensity and environmental conditions for stability studies. Scope This SOP applies to all photostability chambers used for stability studies within…
Lux Meter Usage Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of a lux meter. This ensures accurate measurement of light intensity in photostability chambers and other laboratory environments. Scope This SOP applies to all personnel using lux meters for measuring light intensity within…
Lux Meter Calibration Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of lux meters used in photostability studies and other light intensity measurements. Proper calibration ensures accurate and reliable readings. Scope This SOP applies to all lux meters used for measuring light intensity within the…
UV Meter Usage Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the proper operation of a UV meter. This ensures accurate measurement of ultraviolet light intensity in photostability studies and other laboratory environments. Scope This SOP applies to all personnel using UV meters for measuring ultraviolet light…
UV Meter Calibration Procedure Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for the calibration of UV meters used in photostability studies and other UV light intensity measurements. Proper calibration ensures accurate and reliable readings. Scope This SOP applies to all UV meters used for measuring ultraviolet light intensity…
Procedure for Conducting Freeze Thaw Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting freeze thaw studies. These studies are conducted to evaluate the stability of pharmaceutical products when subjected to cycles of freezing and thawing. Scope This SOP applies to all pharmaceutical products undergoing freeze thaw…
Procedures for Conducting Excipient Compatibility Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting excipient compatibility studies. These studies are performed to evaluate the interaction between active pharmaceutical ingredients (APIs) and excipients used in the formulation. Scope This SOP applies to all excipient compatibility studies conducted within…
Stability studies are critical for assessing the quality, safety, and efficacy of biological products over their intended shelf life. Unlike small molecule drugs, biological products, including vaccines, monoclonal antibodies, and recombinant proteins, often have unique stability requirements due to their complex structure and sensitivity to environmental factors. Proper storage conditions are essential to maintain the…
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