Pharma Secondary Standards

Pharmaceutical Secondary Standards Certificate of Analysis Tracking

From time to time, the Compendial Lots that these Secondary Standards are made traceable to change. This necessitates a requalification of the Secondary Standard Lot against the current lot of Compendial reference standards or substances and a subsequent update to the Certificate of Analysis. The Secondary Standard portfolio is being updated continually with new products and replacement batches of existing products. The latest Secondary Standard information can be found below. For more details, visit Secondary Standards for Pharmaceutical Quality Control.

Updated COA’s can be found by following the material link in the table and entering the batch in the appropriate location.

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COAs for the following products have been updated

Part Number Description Lot #'s Type of Change Date Issued
PHR1108-1G L-Histidine P500108/LRAA7159 Requal vs. USP R006Y0 30 June 2017
PHR1600-1G Topiramate LRAA4716 Requal vs. USP R029Y0 30 June 2017
PHR1657-1G Lincomycin Hydrochloride LRAA5758 CoA Correction- Chemical Formula/Mass Balance 09 June 2017
PHR1117-1G Butylated Hydroxytoluene LRAA7701 & P500117 Requal vs. USP R025270 30 June 2017
PHR1265-1G Carvedilol P500265/LRAA9063 CoA Corection- Impurity Typo 12 June 2017
PHR1096-1G L-Lysine Acetate P500096/LRAA7162 Requal vs. USP R045C0 30 June 2017
PHR1597-1mL CMIT/MIT LRAB0761 CoA Correction MIT Content 13 June 2017
PHR1775-100MG Ranitidine RCC LRAA8551 Requal vs. USP R04740 30 June 2017
PHR1003-1G Aspirin LRAA1476/LRAA7459 CoA Correction - Mass Balance/TCI typo 22 June 2017
PHR1019-1G Benzyl Alcohol LRAA7309 CoA Correction- Assay Value typo 23 June 2017
PHR1579-500MG Ursodiol LRAA4495 Requal vs. EP 3.0 & BP 3897 30 June 2017
PHR1505-50MG Metformin RCB LRAA3639 Requal vs. USP R045P0 30 June 2017
PHR1172-1G L-Valine P500172/LRAA7145 Requal vs. USP R005R0 30 June 2017
PHR1608-1G Lactulose LRAA4724 Requal vs. USP R04530 30 June 2017
PHR1130-1G Potassium Gluconate P500130 Requal vs. USP R03620 30 June 2017
PHR1614-1G Norfloxacin LRAA4873 Requal vs. EP 2.0 30 June 2017
PHR1851-200MG Olmesartan Medoxomil LRAB0088 Requal vs. EP 3.0 30 June 2017
PHR1234-1G Cyanocobalamin LRAB2381 Requal vs. USP F07440 30 June 2017
PHR1055-1G Famotidine P500055/LRAA7133 Requal vs. USP R04S0 & BP 3088 31 July 2017
PHR1883-200MG Docetaxel Trihydrate LRAB0750 Requal vs. EP 3.0 31 July 2017
PHR1847-500MG Ceftazidime LRAB0132 Requal vs. EP 3.0 31 July 2017
PHR1381-1G Aspartame LRAA1637 Requal vs. USP R054U0 31 July 2017
PHR1001-1G Sucrose LRAA6758/LRAA8930/P500001 Requal vs. USP R04310 31 July 2017
PHR1727-40MG Glimepiride RCC (Glimepiride Urethane) LRAB0559 Requal vs. USP R04540 31 July 2017
PHR1348-500MG Saccharin Sodium LRAA1100/LRAA9142 Requal vs. USP R01871/EP 2.0 31 July 2017
PHR1691-100MG 4-Epianhydrothtracycline HCl LRAA6863 Requal vs. EP 7.0 31 July 2017
PHR1345-250MG Thymine (Zidovudine RCC) LRAA1097/LRAA9139 CoA Correction-Update Name 11 July 2017
PHR1978-50MG Ibuprofen RCJ LRAB2591 CoA Correction-Update Name 11 July 2017
PHR1936-10MG Riboflavin Impurity A LRAB2761 CoA Correction-Update Name 11 July 2017
PHR1814-50MG Glipizide RCB LRAA8818 CoA Correction-Update Name 11 July 2017
PHR1813-50MG Glipizide RCA LRAA8817 CoA Correction-Update Name 11 July 2017
PHR1775-100MG Ranitidine RCC LRAB3298/LRAA8551 CoA Correction-Update Name 11 July 2017
PHR1774-100MG Ranitidine RCB LRAA8550 CoA Correction-Update Name 11 July 2017
PHR1773-100MG Ranitidine RCA LRAA8549 CoA Correction-Update Name 11 July 2017
PHR1762-50MG Nevirapine RCC LRAA8555 CoA Correction-Update Name 11 July 2017
PHR1760-50MG Nevirapine RCA LRAA8553 CoA Correction-Update Name 11 July 2017
PHR1761-50MG Nevirapine RCB LRAA8554 CoA Correction-Update Name 11 July 2017
PHR-1756-20MG Bupivacaine RCB LRAA7918 CoA Correction-Update Name 11 July 2017
PHR-1738-40MG Bupivacaine RCA LRAA7909 CoA Correction-Update Name 11 July 2017
PHR-1717-40MG Glimepiride RCC LRAB0559 CoA Correction-Update Name 11 July 2017
PHR-1725-40MG Glimepiride RCA LRAA7400 CoA Correction-Update Name 11 July 2017
PHR-1651-30MG Fluconazole RCA LRAA5498 CoA Correction-Update Name 11 July 2017
PHR1648-30MG Omeprazole RCA LRAB3699/LRAA5495 CoA Correction-Update Name 11 July 2017
PHR1643-200MG 4-Hydroxyisophthalic Acid LRAA4878/LRAB4202 CoA Correction-Update Name 11 July 2017
PHR1495-500MG Trientine HCl LRAA3043 Requal vs. USP R057X0 12 July 2017
PHR1791-100MG Ferulic Acid LRAA8620 CoA Correction-Update CAS# 12 July 2017
PHR1050-1G Benzoic Acid P500050/LRAA8972 Formatting Update 13 July 2017
PHR1434-1G Sodium Metabisulfite LRAA2742 Requal vs. USP R043N0 13 July 2017
PHR1365-1G Lamirudine LRAA1469/LRAA9157 Requal vs. EP 2.0 18 July 2017
PHR1285-1G Lovastatin LRAA0633/LRAA9082 Requal vs. EP 4.0 24 July 2017

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1909-500MG Atenolol LRAB2759
PHR1844-30MG Fluticasone Related Compound D LRAB2755
PHR1843-10MG Fluticasone Related Compound C LRAB4755
PHR1842-10MG Fluticasone Related Compound B LRAB2754
PHR1880-10MG Octreotide Acetate LRAB1954
PHR1875-30MG Valsartan Related Compound A  
PHR1845-50MG Fluticasone Related Compound F LRAA9812
PHR2013-50MG Gabapentin Related Compound E LRAB4760
PHR1979-50MG Gabapentin Impurity G LRAB3286
PHR2010-50MG Pramipexole Related Compound A LRAB4761
PHR2004-50MG Chlorpheniramine Impurity A LRAB4751
PHR1865-500MG Duloxetine HCl LRAB0283
PHR1840-500MG Aminobenzoic Acid LRAA9811

 

The following new batches of existing products were qualified and will be available soon

Part Number Description Lot #
PHR1438-1G Simvastatin LRAB3719
PHR1199-500MG Glucosamine Hydrochloride LRAB3705
PHR1061-1G Valproic Acid LRAB3712
PHR1505-50MG Metformin RCB LRAB5020
PHR1699-100MG Lutein LRAB3708
PHR1065-3x1.2ML Residual Solvents Mixture - Class IIB LRAB3700
PHR1441-1G Spectinomycin Sulfate LRAB3670
PHR1084-500MG Metformin LRAB3694
PHR1401-5G Zinc Pyrithione LRAB3707
PHR1537-1G Oxytetracycline LRAB3717
PHR1022-1G Butylparaben LRAB3701
PHR1033-1G Niacinamide (Nicotinamide) LRAB3696
PHR1605-1G Colistin Sulfate LRAB3703
PHR1599-1G Alendronate Sodium LRAB3753
PHR1054-1G Riboflavin LRAB3710