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 COAs 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
PHR1612 Acetaminophen RCA LRAA4871/LRAB3030 Requal vs USP R107A0 31 July 2020
PHR1967 Albuterol RCA LRAB8449 Requal vs USP R10810 31 July 2020
PHR1703 Natamycin LRAA6969 Requal vs USP R10990 31 July 2020
PHR1703 Natamycin LRAB3619 Requal vs USP R10990 31 July 2020
PHR1703 Natamycin LRAC2803 Requal vs USP R10990 31 July 2020
PHR1488 Quercetin LRAA3036/LRAB3054 Requal vs USP R120F0 31 July 2020
PHR1488 Quercetin LRAB7760 Requal vs USP R120F0 31 July 2020
PHR2033 Rivastigmine RCE LRAB4763 Requal vs USP R103W0 31 July 2020
PHR1375 Ketoprofen LRAA1631/LRAA9164/LRAC3470 Requal vs USP R1104U 31 July 2020
PHR1404 Cyclophosphamide LRAC0295 Requal vs EP 4.0 31 July 2020
PHR1617 Glimepiride LRAA4876 Requal vs EP 3.0 31 July 2020
PHR1617 Glimepiride LRAB7813 Requal vs EP 3.0 31 July 2020
PHR1617 Glimepiride LRAC2892 Requal vs EP 3.0 31 July 2020
PHR1385 Ketoconazole LRAA1641/LRAA9173/LRAC3465 Requal vs EP 3.0 31 July 2020
PHR1569 Levocarnitine LRAB7787 CoA Content Update 31 July 2020
PHR1864 Brompheniramine Maleate LRAB0504 Requal vs USP R104A0 31 July 2020
PHR2097 Betahistine HCl LRAB8609 Requal vs BP 4219 31 July 2020
PHR1881 Articaine HCl LRAB0608 Requal vs EP 4.0 31 July 2020
PHR1002 Fructose P500002/LRAA8955 Requal vs EP 2 31 July 2020
PHR1002 Fructose LRAB2150 Requal vs EP 2 31 July 2020
PHR1002 Fructose LRAC0254 Requal vs EP 2 31 July 2020
PHR1948 Sodium Carbonate LRAB0983 Requal vs USP R097Q0 31 July 2020
PHR1347 Tromethamine LRAA1099/LRAA9141/LRAC3703 Requal vs USP R104D0 31 July 2020
PHR1524 Tamsulosin HCl LRAC0288 Requal vs EP Batch 2.0 31 July 2020
PHR1524 Tamsulosin HCl LRAA3642/LRAC0156 Requal vs EP Batch 2.0 31 July 2020
PHR1651 Fluconazole RCA LRAA5498/LRAC1231 Requal vs EP Batch 6.0 31 August 2020
PHR1068 Edetate Disodium LRAC0266 CoA Content Update 12 August 2020
PHR1281 Albendazole LRAA0016/LRAA9078 Requal vs USP R110M0/BP Batch 4094 31 August 2020
PHR1030 Alpha-Tocopheryl Acetate LRAC1696 Requal vs USP R03530 31 August 2020
PHR1030 Alpha-Tocopheryl Acetate LRAB3630 Requal vs USP R03530 31 August 2020
PHR1413 Ethosuximide LRAA2477/LRAA9197/LRAC3706 Requal vs USP R119F0 31 August 2020
PHR1160 Fluconazole LRAC0255 Requal vs USP R10940 31 August 2020
PHR1160 Fluconazole LRAA9717 Requal vs USP R10940 31 August 2020
PHR1555 Hexane LRAB5023 Requal vs USP R084L0 31 August 2020
PHR1555 Hexane LRAA4471/LRAB3835 Requal vs USP R084L0 31 August 2020
RTC000084 Hexane LRAB9797 Requal vs USP R084L0 31 August 2020
PHR1004 Ibuprofen LRAA8931/LRAC0253 Requal vs BP 4105 31 August 2020
PHR1131 Verapamil Hydrochloride LRAA5980 / LRAC0587 Requal vs EP 2.0 31 August 2020
PHR1722 Triamterene LRAB9729 Requal vs USP R123T0 31 August 2020

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR2777 Promethazine Related Compound B LRAC6264
PHR2613 Selenomethionine (racemic) LRAC6193
PHR2598 Furazolidone LRAC6175
PHR2834 Nilotinib Related Compound A LRAC6586
PHR2303 Ropivacaine Hydrochloride LRAC6396
PHR2640 Penicillin G Potassium LRAC5998
PHR2582 Gemcitabine Hydrochloride LRAC6253
PHR2831 Amantadine Related Compound A LRAC6584
PHR2581 Indomethacin Related Compound B LRAC6252
PHR2829 Adapalene Related Compound C LRAC6668
PHR2897 Corn Oil LRAC6778
PHR2801 Ethylhexyl Triazone LRAC6454
PHR2822 Acamprosate Related Compound A LRAC6577
PHR2832 Amantadine Related Compound B LRAC6671
PHR2629 Hydroxyurea LRAC5960
PHR2818 Mesna Related Compound A LRAC6440
PHR2625 Desosaminylazithromycin LRAC6267
PHR2309 Loratadine Related Compound C LRAC5327
PHR2571 Ropivacaine LRAC6562
PHR2850 Capecitabine Related Compound B LRAC6692
PHR2817 Pyroglutamic Acid LRAC6444
PHR2842 Azelastine Related Compound D LRAC6680
PHR2462 Glutathione Impurity A LRAC4778
PHR2841 Azathioprine Related Compound A LRAC6679
PHR2845 Buspirone Related Compound A LRAC6683
PHR2608 Probenecid LRAC6191
PHR2691 Hyperoside LRAC6271
PHR2538 Olanzapine Related Compound C LRAC5771
PHR2134 4-Isobutylstyrene LRAC5351
PHR2130 1-Ethyl-4-isobutylbenzene LRAC5353
PHR2125 2-(4-Isobutyrylphenyl)propane LRAC5356
PHR2540 Sodium Picosulfate LRAC6136
PHR2326 Guaifenesin Impurity D LRAC5318
PHR2535 Sertraline Hydrochloride LRAC6133
PHR2630 Levomedetomidine LRAC6388
PHR2847 Buspirone Related Compound K LRAC6688
PHR2849 Capecitabine Related Compound A LRAC6691
PHR2578 N-[4-[(5-methylisoxazol-3-yl)sulfamoyl]phenyl]acetamide LRAC6035
PHR2612 Isopropyl Valproate LRAC6891
PHR2840 Atomoxetine Related Compound A LRAC6677
PHR2566 Propofol Related Compound B EP Impurity J LRAC6528
PHR2696 Mogroside V LRAC6278
PHR2617 (2RS)-2-(3,4-dimethoxyphenyl)-5-[[2-(3,4-dimethoxy-phenyl)ethyl]amino]-2-(1-methylethyl)pentanenitrile (N-norverapamil) LRAC6380
PHR2444 Diclofenac Impurity B LRAC4773
PHR2910 Famotidine Related Compound C LRAC6633
PHR2926 Methyl Acetate LRAC6732

 

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

Part Number Description Lot #
PHR1329 Potassium Chloride LRAC6374
PHR1004 Ibuprofen LRAC5691
PHR1533 Cholesterol LRAC6502
PHR1921 Clobetasol Propionate LRAC6669
PHR2107 Acetaldehyde LRAC6402
PHR1603 Montelukast Sodium LRAC5690
PHR1170 Residual Solvent Class II - Methanol LRAC6416
PHR1555 HEXANE LRAC7311
PHR1880 Octreotide Acetate LRAC6386
PHR1731 Nitisinone LRAC0575
PHR1235 Retinyl Palmitate LRAC7147
PHR1239 BETA CAROTENE LRAC6781
PHR1239 Beta Carotene LRAC7466
PHR1094 Phenacetin Melting Point Standard LRAC6418
PHR1667 t-Amyl Alcohol LRAC2141