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
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
PHR1438-1G Simvastatin LRAA2746/LRAA9215/LRAB3719 Requal vs. USP R05290 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
PHR1448-500MG Sulfadimethoxine LRAB5199 Update Storange 31 May 2018
PHR1586-1G Oleic Acid LRAB3687 Requal vs. USP R04930 31 May 2018
PHR1054-1G Riboflavin LRAB3710/LRAA7713 Requal vs. EP 5.0 31 May 2018
PHR1699-3X100MG Lutein LRAA6965/LRAB3708 Requal vs. USP R045E0 31 May 2018
PHR1605-1G Colistin Sulfate LRAB3703 Correcting Total Polymyxin Content from 93.0% to 93.7% 11 June 2018
PHR1382-1G Ceftriaxone Na LRAA1638/LRAA9170 Requal vs. USP R07420; EP: 3952 13 June 2018
PHR1054-1G Riboflavin LRAB3710/LRAA7713 Update Concentration in UV Method 19 June 2018
PHR1017-500MG Phenylephrine HCl P50017/LRAA6208/LRAA9501 Requal vs. USP R06060; BP 3805 30 June 2018
PHR1697-1G Levofloxacin Hemihydrate LRAA6963 Requal vs. USP R07580 30 June 2018
PHR1064-3X1.2ML Residual Solvents Mixture Class IIA LRAA2891/LRAA7263/LRAB0284 Requal vs. USP R058X0 30 June 2018
PHR1061-1G Valproic Acid P500061/LRAA8434/LRAA5978/LRAB3712 Correcting Storage 30 June 2018
PHR1331-500MG Cyanoguanidine LRAA0834/LRAA9125 Requal vs. USP R072Y0; EP:2.0 30 June 2018
PHR1084--500MG Metformin HCl LRAB3694/LRAA1730/LRAA8975 Requal vs. USP R069H0 30 June 2018
PHR1414-1G Methyl Stearate LRAB2971 Requal vs. USP R061N0 30 June 2018
PHR1044-1G Ciprofloxacin HCl LRAB3671/LRAA8718 Requal vs. USP R05170 30 June 2018
PHR1687-3X1.2ML Cyclohexane LRAA6303 Requal vs. USP R047N0 30 June 2018
PHR1162-1G Loperamide HCl P500162/LRAA8994 Requal vs USP R058D0 30 June 2018
PHR1292-1G Zidovudine LRAA0303/LRAA9088 Requal vs USP R052L0 30 June 2018
PHR1204-1G Benzophenone P500204/LRAA9018 Requal vs USP R066B0 30 June 2018
PHR1058-1G Clotrimazole P500058/LRAA7129/LRAB9112 Requal vs USP R063A0 30 June 2018
PHR1460-500MG Choline Bitartrate LRAA3008/LRAB3329 Requal vs USP R05960 30 June 2018
PHR1626-1G Valganciclovir LRAA5295/LRAB9043 Requal vs USP R07160 30 June 2018
PHR1152-1G Phenyl Salicylate Melting Point Standard P500152/LRAA7176 Requal vs USP R062L0 30 June 2018
PHR1856-1G Quetiapine Fumarate LRAB0282 Requal vs USP R065W0 30 June 2018
PHR1436-1G Foscarnet Na LRAA3051/LRAB4888 Requal vs EP 2.0 30 June 2018
PHR1155-1G Octyldodecanol P500155/LRAA7139 Requal vs USP R059P0 30 June 2018
PHR1124-1G Myristic Acid P500124/LRAA7148 Requal vs USP R06070 30 June 2018
PHR1145-1G Doxycycline Hyclate P500145/LRAA6906 Requal vs USP R065H0; BP 4017 30 June 2018
PHR1870-30MG Atorvastatin Related Compound C LRAB7553 Requal vs EP 3.0 30 June 2018
PHR1959-50MG Salbutamol Impurity B LRAB3289 Update MW : 209.28 30 June 2018
PHR1854-200MG Candesartan Cilexetil LRAB0135 Requal vs USP R06000 30 June 2018
PHR1232-500MG Calcium-D-Pantothenate LRAA8436 Requal vs USP R029P0 30 June 2018
PHR1232-500MG Calcium-D-Pantothenate LRAB3618 Requal vs USP R029P0 30 June 2018
PHR1258-1G Chloroquine Phosphate P500258 Requal vs USP R075S0 30 June 2018
PHR1258-1G Chloroquine Phosphate LRAA9061 Requal vs USP R075S0 30 June 2018
PHR1258-1G Chloroquine Phosphate LRAB3715 Requal vs USP R075S0 30 June 2018
PHR1018-500MG Dextromethorphan Hydrobromide P500018 Requal vs EP 5.0 30 June 2018
PHR1018-500MG Dextromethorphan Hydrobromide LRAA5631 Requal vs EP 5.0 30 June 2018
PHR1018-500MG Dextromethorphan Hydrobromide LRAA9503 Requal vs EP 5.0 30 June 2018
PHR1135-1G Myristyl Alcohol P500135 Requal vs USP R064X0 30 June 2018
PHR1135-1G Myristyl Alcohol LRAA7155 Requal vs USP R064X0 30 June 2018
PHR1869-30MG Atorvastatin RCB LRAB1035 Requal vs USP R06230 30 June 2018

 

The following new products were qualified and will be available soon

Product No. Description Lot #
PHR1929-500MG Ubidecarenone LRAB0979
PHR2007-50MG Allopurinol Related Compound C LRAB7873
PHR1949-2G Sodium Lauryl Sulfate LRAB0984
PHR2038-50MG Caffeine Impurity B LRAB8373
PHR1981-50MG Allopurinol Related Compound F LRAB3287
PHR1623-3ML Travoprost LRAA5292
PHR2072-500MG Efavirenz LRAB8364
PHR1981-50MG Allopurinol Related Compound D LRAB7874
PHR2009-50MG Allopurinol Related Compound E LRAB7871
PHR2069-50MG Efavirenz Related Compound B LRAB8451
PHR2070-50MG Efavirenz Related Compound C LRAB8452
PHR1993-50MG Diphenhydramine Related Compound A LRAB4753
PHR1967-30MG Albuterol Related Compound A LRAB8449
PHR2068-50MG Efavirenz Related Compound A LRAB8450
PHR2012-20MG Gabapentin Related Compound D LRAB8476
PHR2040-50MG Albuterol Related Compound B LRAB8441
PHR2061-1G Amiloride Related Compound A LRAB8475

 

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

Product No. Description Lot #
PHR1574-100MG Phenytoin Related Compound A 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
PHR1770-5x100MG Lycopene LRAB7762
PHR1701-1G Triamcinolone Acetonide LRAB5529
PHR1015-1G Diphenhydramine HCl LRAB7790
PHR1799-500MG Meloxicam LRAB7807
PHR1100-1G L-Phenylalanine LRAB9001
PHR1626-1G Valganciclovir HCl LRAB9043
PHR1113-1G Sodium Lactate LRAB9051
PHR1457-1G Calcium Lactobionate LRAB9052
PHR1017-500MG Phenylephrine HCl LRAB7786
PHR1697-1G Levofloxacin Hemihydrate LRAB7828
PHR1064-3X1.2ML Residual Solvents Mixture Class IIA LRAB7797
PHR1098-1G N-Acetyl-L-Cysteine LRAB9085
PHR1613-1G Levothyroxine LRAB9086
PHR1139-1G Phenytoin LRAB7779
PHR1109-1G Taurine LRAB9111
PHR1058-1G Clotrimazole LRAB9112
PHR1514-1G Disodium Guanylate LRAB9113
PHR1570-500MG Mesna LRAB9114
PHR1012-1G Methylparaben LRAB7793
PHR1055-1G Famotidine LRAB9138
PHR1057-1G Furosemide LRAB9162
PHR1591-500MG Atovaquone LRAB9163
PHR1135-1G Myristyl Alcohol LRAB9198
PHR1168-1G Ofloxacin LRAB9185
PHR1585-1G Esomeprazole Magnesium LRAB9227
PHR1295-1.2ML Ethylene Oxide Stock Solution LRAB7763
PHR1854-200MG Candesartan Cilexetil LRAB8504
PHR1075-1G Cimetidine LRAB9254
PHR1104-1g L-Aspartic acid LRAB9272
PHR1173-1g N-Acetyl-L-tyrosine LRAB9273