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
PHR1031-500MG alpha-Tocopherol LRAA7704 Requal vs. EP 8.0 1 November 2017
PHR1404-1G Cyclophosphamide LRAB3626 CoA Correction- Mass Balance 1 November 2017
PHR1114-1G Stearic Acid P500114/LRAA7125 Requal vs. EP 4.0 2 November 2017
PHR1044-1G Ciprofloxacin Hydrochloride P500044/LRAA8718/LRAB3671 Requal vs. EP 6.0 2 November 2017
PHR1489-1G L-Arabinitol LRAA3037 Requal vs. USP R05730 3 November 2017
PHR1643-200MG 4-Hydroxyisophthalic acid (Salicylic Acid Related Compound B) LRAB6873 Alias of LRAB6873 6 November 2017
PHR1234-1G Cyanocobalamin LRAB2381 CoA Correction- EP/BP assignment 17 November 2017
PHR1595-500MG Polymyxin B Sulfate LRAA4711 Requal vs. USP R046V0 20 November 2017
PHR1559-1G Bacitracin Zinc LRAA4580 Requal vs. USP R048C0 20 November 2017
PHR1290-1G Nifedipine LRAA0488/LRAA9087 Requal vs. USP R051Q0 30 November 2017
PHR1601-1G Valacyclovir Hydrochloride LRAA4717 Requal vs. USP R053Q0 30 November 2017
PHR1456-2x1G Bis-2-(Ethylhexyl)maleate LRAA3004/LRAA9222 Requal vs. USP R04300 30 November 2017
PHR1140-500MG Ketorolac Tromethamine P500140/LRAA7191 Requal vs. USP 04580; EP: 2.0 30 November 2017
PHR1918-50MG Carbamazepine Related Compound A LRAB1417 Requal vs. USP R045K0 30 November 2017
PHR1648-30MG Omeprazole Sulfone LRAA5495/LRAB3699 Requal vs. USP R022U1; EP 3.0 30 November 2017
PHR1533-500MG Cholesterol LRAA3651/LRAB3056 Requal vs. USP R062D0 29 December 2017
PHR1043-500MG Prednisolone LRAA6903/P500043 Requal vs. USP R052D0; EP 9.0; BP: 3756 29 December 2017
PHR1586-1G Oleic Acid LRAA4565/LRAB3687 Requal vs. EP 2.0 29 December 2017
PHR1050 Benzoic Acid P500050/LRAA8972/LRAB1935 Requal. vs UPS R044Q0 (P500050/LRAA8972/LRAB1935); Requal. vs EP 1.0 (LRAB1935) 29 December 2017
PHR1090-1G Dopamine HCl P500090/LRAA7131 Requal vs. USP R038X0; BP: 3542 29 December 2017
PHR19801-500MG Minocycline HCl LRAA9571 Requal vs. EP 4.0 29 December 2017
PHR1717-500MG Methylprednisolone LRAA7305 Requal vs. EP 4.0 29 December 2017
PHR1042-1G Prednisone P500042/LRAA8969 Requal vs. EP 5.0 29 December 2017
PHR1067-1G Carbamazepine P500067/LRAA6055 Requal vs. USP R058M0 29 December 2017
PHR1377-1G Allopurinol LRAA1633/LRAA9166 Requal vs. USP R05890 29 December 2017
PHR1306-1G 3-tert-butyl-4-hydroxyanisole LRAA0066/LRAA9102 Requal vs. USP R043W0 29 December 2017
PHR1309-3G Dimethyl Sulfoxide LRAA0526/LRAA9105 Requal vs. USP R056E0 29 December 2017
PHR1103-1G L-Serine P500103 / LRAA7166 Requal vs. EP 2.0 29 December 2017
PHR1072-3x1.2ML 2-Propanol LRAB7370 Alias of LRAB3749 3 January 2018

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1913-500MG Bisoctrizole LRAB0910
PHR1917-500MG Buspirone Hydrochloride LRAB2760
PHR2028-50MG Ibuprofen Impurity H LRAB6568
PHR1912-250MG Benazepril Hydrochloride LRAB0978
PHR2039-500MG Xylometazoline Hydrochloride LRAB6411
PHR1956-200MG D-Glucuronic Acid LRAB1667
PHR1905-25MG Citalopram Related Compound G LRAB2757
PHR1954-30MG N'-Methyl omeprazole LRAB1236

 

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

Part Number Description Lot #
PHR1235-1G Retinyl Palmitate LRAB6688
PHR1502-500MG Berberine Chloride LRAB5522
PHR1373-5x1.2ML Alcohol LRAB6749
PHR1070-5x1.2ML Dehydated Alcohol LRAB6843
PHR1759-20MG Thioxothiamine LRAB3704
PHR1748-3x1.5mL Glacial Acetic Acid LRAB6750
PHR1702-200MG Fluticasone Propionate LRAB5523
PHR1733-1G Escitalopram Oxalate LRAB5520
PHR1118-1G Propyl Gallate LRAB7102
PHR1497-1G Maltose Monohydrate LRAB5526