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.

If you wish to be notified of this monthly update by email, please sign up here: COA Updates.

 

COAs for the following products have been updated

Part Number Description Lot #'s Type of Change Date Issued
PHR1733-1G Escitalopram Oxalate LRAB5520; LRAA8002 Requal vs. EP 1.0 04 April 2018
PHR1275-1G Naphthalene LRAA9072 Requal vs. USP R050R0 06 April 2018
PHR1001-1G Sucrose LRAA8930 / LRAA6758 Requal vs. USP R04311; EP 2.0 10 April 2018
PHR1047-1G Phenol P500047 / LRAA8971 Requal vs. USP R06550 30 April 2018
PHR1736-1G Venlafaxine HCl LRAA8042 Requal vs. BP 3841 30 April 2018
PHR1557-3X1.2ML Methylene Chloride LRAA8514 Requal vs. EP 4.0 30 April 2018
PHR1061-1G Valproic Acid P500061 / LRAA5978; LRAB3712; LRAA8434 Requal vs. USP R051T0 30 April 2018
PHR1476-1G Diethyl Phthalate LRAA9225 Requal vs. EP 2.0 30 April 2018
PHR1369-500MG Thiamine Pyrophosphate LRAA1473 / LRAA9196 Requal vs. USP R03990 30 April 2018
PHR1030-500MG α-Tocopheryl Acetate LRAA4475 / LRAA7703 / LRAB3630 Requal vs. EP 10.0 30 April 2018
PHR1553-3X1.2ML Dimethylformamide LRAA8513 / LRAA4469 Requal vs. USP R04410 30 April 2018
PHR1643-200MG 4-Hydroxyisophthalic acid (Salicylic Acid RCB) LRAA4878 / LRAB4202 / LRAB6873 Requal vs. USP R066V0 30 April 2018
PHR1410-1G Triacetin LRAA2474 / LRAA9194 Requal vs. USP H2H083 30 April 2018
PHR1660-1G Indapamide LRAA5761 Requal vs. EP 6.0 30 April 2018
PHR1413-1G Ethosuximide LRAA2477 / LRAA9197 Requal vs. EP 2.0; BP 3456 30 April 2018
PHR1815-50MG Glipizide Related Compound A LRAA8819 Requal vs. USP R064B0 30 April 2018
PHR1021-1G Clindamycin Phosphate P500021 / LRAA8960 Requal vs. USP R06300; EP 3.0 30 April 2018
PHR1118-1G Propyl Gallate P500118 / LRAB7102 Requal vs. USP R043H1 30 April 2018
PHR1406-1G Urea LRAA2470 / LRAA9190 Requal vs. USP R073L0 30 April 2018
PHR1321-5G Sodium Chloride LRAA0824 / LRAA9115 Requal vs. USP R047R0 30 April 2018
PHR1003-1G Aspirin LRAA7459 / LRAA1476 Requal vs. USP R059R0 31 May 2018
PHR1050-1G Benzoic Acid P500050/LRAA8972/LRAB1935 Requal vs. EP 2.0 31 May 2018
PHR1624-200MG Cisplatin LRAA5492 Requal vs. BP 3211 31 May 2018
PHR1105-1G L-Leucine P500105/LRAA6929 Requal vs. EP 3.0 31 May 2018
PHR1215-3x1.5ML Lactic Acid P500215/LRAA9028 Requal vs. USP R047M0 31 May 2018
PHR1013-1G Salicylic Acid LRAB0140/LRAA6961 Requal vs. EP 3.0; BP 2810 31 May 2018
PHR1133-1G Cetyl Alcohol P500133/LRAA7153/LRAB3383 Requal vs. EP 3.0 31 May 2018
PHR1467-1G Promethazine Hydrochloride LRAA3015/LRAA9223 Requal vs. USP R067C0 31 May 2018
PHR1024-1G Lactose Monohydrate P500189/LRAA8921 Requal vs. EP 2.0 31 May 2018
PHR1289-1G Enalapril Maleate LRAA0302/LRAA9086 Requal vs. USP R06660 31 May 2018
PHR1329-5G Potassium Chloride LRAA0832/LRAA9123 Requal vs. USP R071U0 31 May 2018
PHR1537-1G Oxytetracycline LRAA3655/LRAB4155/LRAB3717 Requal vs. USP R05720 31 May 2018
PHR1754-30MG Bupropion Related Compound C LRAA8556 Requal vs. USP R060N0 31 May 2018

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1910-50MG Ciprofloxacin Related Compound A LRAB0748
PHR1925-500MG Dorzolamide HCl LRAB1664
PHR1868-30MG Atorvastatin Related Compound A LRAB7552
PHR1996-20MG Thiamine Impurity A LRAB8023
PHR1998-20MG Thiamine Impurity C LRAB8021
PHR1931-1G Iohexol LRAB0957
PHR2031-30MG Rivastigmine Related Compound C LRAB7975
PHR1919-500MG Chlorzoxazone LRAB0913
PHR1571-1G Methyl Oleate LRAA4487
PHR2029-30MG Rivastigmine Related Compound A LRAB7622
PHR2032-100MG Rivastigmine Related Compound D LRAB7972
PHR2033-30MG Rivastigmine Related Compound E LRAB4763
PHR2030-30MG Rivastigmine Related Compound B LRAB4762
PHR1929-500MG Ubidecarenone LRAB0979
PHR2007-50MG Allopurinol Related Compound C LRAB7873
PHR1949-2G Sodium Lauryl Sulfate LRAB0984
PHR2038-50MG Caffeine Impurity B LRAB8373

 

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

Part Number Description Lot #
PHR1597-1ML CMIT/MIT LRAB7781
PHR1006-1G Sorbitol LRAB7795
PHR1736-1G Venlafaxine HCl LRAB7761
PHR1009-1G Caffeine LRAB7780
PHR1574-100MG Phenytoin RCA LRAB8640
PHR1003-1G Aspirin LRAB7669
PHR1050-1G Benzoic Acid LRAB8257
PHR1624-200MG Cisplatin LRAB7778
PHR1767-500MG Melatonin LRAB8251
PHR1000-1G Dextrose LRAB7785
PHR1488-1G Quercetin LRAB7760
PHR1934-20MG Ibuprofen Impurity B LRAB8256
PHR1005-10G Acetaminophen LRAB7782
PHR1329-5G Potassium Chloride LRAB7667
PHR1352-2G N-Methylpyrrolidone LRAB8250
PHR1130-1G Potassium Gluconate LRAB8904
PHR1096-1G L-Lysine Acetate LRAB8916
PHR1060-1G Mesalamine LRAB8917
PHR1770-100MG Lycopene LRAB7762