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
PHR1233-1G Biotin LRAB6597 Alias of LRAA9042 6 October 2017
PHR1862-20MG Fluconazole Related Compound B LRAB0138 Requal vs. USP R05370 6 October 2017
PHR1104-1G L-Aspartic Acid P500104/LRAA7167 Requal vs. USP R05750 6 October 2017
PHR1425-1G Benzethonium Chloride LRAA2733/LRAA9207 Requal vs. USP R026T0 9 October 2017
PHR1541-1G Leucovorin Calcium LRAA4187 Requal vs. USP R063P0; EP 7.0; BP 3855 9 October 2017
PHR1524-200MG Tamsulosin Hydrochloride LRAA3642 Requal vs. USP R041N0 10 October 2017
PHR1019-1G Benzyl Alcohol LRAA3986 + LRAA7309 Requal vs. EP 3.0 11 October 2017
PHR1206-500MG Galactose P500206 + LRAA9020 Requal vs. USP R047C0 12 October 2017
PHR1886-1G Memantine Hydrochloride LRAB0640 Requal vs. USP R044E0 13 October 2017
PHR1465-500MG Pantolactone LRAB6698 Alias of LRAA3013 17 October 2017
PHR1755-30MG Bupropion Related Compound F LRAA8557 CoA Correction_Update Product's Name 17 October 2017
PHR1602-1G Losartan Potassium LRAB1233 CoA Correction- Chromatographic Impurity 18 October 2017
PHR1120-1G Palmitic Acid P500120/LRAA6510 Requal vs. USP R029M1 19 October 2017
PHR1480-200MG Ethinyl Estradiol LRAA9226/LRAA3028 Requal vs. BP 3809 24 October 2017
PHR1032-1G Hydrochlorothiazide P500062/LRAA6504 Requal vs. EP 8.0 31 October 2017
PHR1761-50MG Nevirapine Related Compound B LRAA8554 Requal vs. USP R046B0 31 October 2017
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
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

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1970-100MG Acetaminophen Impurity C LRAB2775
PHR1971-100MG Acetaminophen Impurity E LRAB2776
PHR1972-100MG Acetaminophen Impurity G LRAB5677
PHR1973-100MG Acetaminophen Impurity I LRAB2777
PHR1890-50MG Tiotropium Bromide Monohydrate LRAB0347
PHR1889-500MG Rizatriptan Benzoate LRAB0554
PHR1898-50MG Diphenhydramine N-Oxide HCl LRAB0342
PHR1822-50MG Budesonide Related Compound G LRAB0430
PHR1876-30MG Valsartan Related Compound B LRAB1042
PHR1878-30MG Valsartan Related Compound E LRAB1044
PHR1869-30MG Atorvastatin Related Compound B LRAB1035
PHR1872-30MG Atorvastatin Related Compound E LRAB1038
PHR1874-30MG Atorvastatin Related Compound I LRAB1040
PHR1873-30MG Atorvastatin Related Compound H LRAB1039
PHR1988-30MG Omeprazole Impurity C LRAB6379
PHR1722-500MG Amantadine Hydrochloride LRAA7299
PHR1911-300MG Azacitidine LRAB1224
PHR1987-30MG Omeprazole Impurity B LRAB4099
PHR1918-50MG Carbamazepine Related Compound A LRAB1417
PHR2034-50MG Rivastigmine Related Compound F LRAB6410
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

 

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

Part Number Description Lot #
PHR1572-500MG Oxymetazoline Hydrochloride LRAB5024
PHR1480-200MG Ethinyl Estradiol LRAB3673
PHR1219-3x1.5ML Acetone LRAB5525
PHR1072-1.2ML 2-Propanol LRAB3749
PHR1579-500MG Ursodiol LRAB5519
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