Validation of Pharma Transport

Temperature controlled vehicles are used to transit the medicinal products. These vehicles should be validated for the controlled environmental conditions before use. Compartment should be mapped for temperature and humidity for a time period equal to the actual time taken in transit of product. T…

81 Antibiotics - Microbial Assays

The activity (potency) of antibiotics may be demonstrated under suitable conditions by their inhibitory effect on microorganisms. A reduction in antimicrobial activity also will reveal subtle changes not demonstrable by chemical methods. Accordingly, microbial or biological assays remain generally …

BET - Gel-Clot Technique

The Gel-Clot Technique is for detecting or quantifying endotoxins based on clotting of the lysate reagent in the presence of endotoxin. The minimum concentration of endotoxin required to cause the lysate to clot under standard conditions is the labeled sensitivity of the lysate reagent. To ensure b…

Determination Of Maximum Valid Dilution (MVD)

The Maximum Valid Dilution is the maximum allowable dilution of a specimen at which the endotoxin limit can be determined. Determine the MVD from the following equation: MVD = (Endotoxin Limit × Concentration of Sample Solution)/() Endotoxin Limit—The endotoxin limit for parenteral drugs, defined on …

171 - Vitamin B12 Activity Assay

USP Reference Standards 11— USP Cyanocobalamin RS.
Assay Preparation— Place a suitable quantity of the material to be assayed, previously reduced to a fine powder if necessary and accurately measured or weighed, in an appropriate vessel containing, for each g or mL of material taken, 25 mL of an aq…

161 - Transfusion And Infusion Assemblies And Similar Medical Devices

The requirements apply to sterile and nonpyrogenic assemblies or devices in contact directly or indirectly with the cardiovascular system, the lymphatic system, or cerebrospinal fluid. This includes, but is not limited to, solution administration sets, extension sets, transfer sets, blood administr…

151 - Pyrogen Test

This test is intended for the evaluation of the biological adequacy, as an index to the completeness of the mixture of amino acids contained, of Protein Hydrolysate Injection.
Depletion Diet— Parts by Weight Dextrin 83.9 Corn Oil 9.0 Salt Mixture 4.0 Agar 2.0 Cod Liver Oil 1.0 Choline Chloride 0.15 Inositol 0.10 C…

141 - Protein - Biological Adequacy Test

This test is intended for the evaluation of the biological adequacy, as an index to the completeness of the mixture of amino acids contained, of Protein Hydrolysate Injection.
Depletion Diet— Parts by Weight Dextrin 83.9 Corn Oil 9.0 Salt Mixture 4.0 Agar 2.0 Cod Liver Oil 1.0 Choline Chloride 0.15 Inositol 0.10 C…