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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Telmisartan Impurity 5 Telmisartan Impurity 5 885046-20-8 C19H19ClN4
Tinidazole Impurity 2 Tinidazole Impurity 2 140165-55-5 C6H12N2O4S
3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one hydrochloride 3-[3-({[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-1,3-dihydro-2H-3-benzazepin-2-one hydrochloride 1086026-38-1 C27H34N2O5*ClH
Amoxicillin Impurity Z Amoxicillin Impurity Z C16H19N3O5S
Amoxicillin Impurity Z Amoxicillin Impurity Z C16H19N3O5S
Atracurium Impurity P Atracurium Impurity P
Atracurium Impurity U Atracurium Impurity U
Ceftazidime side chain Impurity Ceftazidime side chain Impurity
Linagliptin Impurity 35 Linagliptin Impurity 35
Ropivacaine Impurity 1 Ropivacaine Impurity 1
Ropivacaine Impurity 46 Ropivacaine Impurity 46
Sugammadex sodium Org199425-1 Impurity Sugammadex sodium Org199425-1 Impurity
Sugammadex sodium Org244517-1 Impurity Sugammadex sodium Org244517-1 Impurity
Terbutaline Impurity 11 Terbutaline Impurity 11 2387020-93-9 C8H7BrO3
(2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((R)-tetrahydrofuran- 3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H- pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(4-chloro-3-(4-(((R)-tetrahydrofuran- 3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H- pyran-3,4,5-triol C23H27ClO7
Afatinib impurity 34 Afatinib impurity 34 2475095-50-0 C14H7ClF2N4O2
Avibactam Impurity 39 Avibactam Impurity 39 2089462-91-7 C15H22N2O3
Butyphthalide impurity 28 Butyphthalide impurity 28
Butyphthalide impurity 36 Butyphthalide impurity 36 2245275-82-3 C15H18O5
Canagliflozin Impurity 32 Canagliflozin Impurity 32
Carbocistein Impurity B Carbocistein Impurity B
Celecoxib Impurity 22 Celecoxib Impurity 22 921617-76-7 C17H13F3N2O3S
Emtricitabine Impurity RRO Emtricitabine Impurity RRO
Febuxostat Impurity 84 Febuxostat Impurity 84
Febuxostat Impurity 89 Febuxostat Impurity 89
Gefitinib Impurity T Gefitinib Impurity T
Ibrutinib Impurity 16 Ibrutinib Impurity 16
LCZ696(valsartan + sacubitril) impurity 35 LCZ696(valsartan + sacubitril) impurity 35
Lenvatinib Impurity 15 Lenvatinib Impurity 15
Montelukast sodium impurity I Montelukast sodium impurity I
Moxifloxacin Impurity 48 Moxifloxacin Impurity 48
Olsalazine Impurity A Olsalazine Impurity A
Ozagrel impurity E Ozagrel impurity E
Solifenacin impurity 22 Solifenacin impurity 22
Sunitinib Impurity YDEJ Sunitinib Impurity YDEJ
Tofacitinib Impurity 94 Tofacitinib Impurity 94
Topiroxostat Impurity 31 Topiroxostat Impurity 31
Sitafloxacin Impurity 9 Sodium Salt Sitafloxacin Impurity 9 Sodium Salt
Azilsartan Impurity 11 Azilsartan Impurity 11 91526-16-8 C12H12O6S
Pitavastatin Impurity 18 Sodium Salt Pitavastatin Impurity 18 Sodium Salt 1611499-16-1 C25H24FNO5
Apixaban Impurity 25 Apixaban Impurity 25 2133292-60-9 C26H27ClN4O5
Saxagliptin Impurity 10 Saxagliptin Impurity 10
(1r,4r)-4-((2-amino-4-bromobenzyl)amino)cyclohexan-1-ol hydrochloride (1r,4r)-4-((2-amino-4-bromobenzyl)amino)cyclohexan-1-ol hydrochloride C13H20BrClN2O
Aztreonam Impurity 6 Aztreonam Impurity 6
Cetirizine impurity 14 Cetirizine impurity 14 C21H25ClN2O3
Vitamin B1 Impurity 1 Vitamin B1 Impurity 1 C12H17ClN4OS
Diquafosol Impurity UP2U Diquafosol Impurity UP2U 221169-12-6 C18H25N4NaO17P2
Pemetrexed disodium  Impurity Pemetrexed disodium Impurity 17405-00-4 C7H5ClN2O2
Vonoprazan Impurity Z-1 Vonoprazan Impurity Z-1
IPC-Mixed Tenofovir Trimer IPC-Mixed Tenofovir Trimer
Olanzapine impurity M Olanzapine impurity M C17H20N4S
Afatinib impurity 41 Afatinib impurity 41 69169-63-7 C5H9NO2
Vildagliptin Impurity 38 Vildagliptin Impurity 38 956508-24-0 C10H16N2O3
Tazobactam Impurity C Tazobactam Impurity C
6-HYDROXY ONDANSETRON 6-HYDROXY ONDANSETRON 110708-17-3 C18H19N3O2
8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one 8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one 31251-41-9 C14H10ClNO
(R)-Ornidazole (R)-Ornidazole 166734-80-1 C7H10ClN3O3
Apixaban Impurity 22 Apixaban Impurity 22 1449510-64-8 C25H26ClN5O4
Cefdinir impurity TU mixture Cefdinir impurity TU mixture
Fotagliptin Impurity 1 Fotagliptin Impurity 1
Rocuronium bromide Impurity 7 Rocuronium bromide Impurity 7
Tofacitinib Impurity 69 Tofacitinib Impurity 69
Benzenamine, 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)- Benzenamine, 3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)- 641571-06-4 C11H10F3N3
Ciprofloxacin EP Impurity E Ciprofloxacin EP Impurity E 879005-96-6 C16H20FN3O
ethyl 2-(3-cyano-4-propoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-propoxyphenyl)-4-methylthiazole-5- carboxylate C17H18N2O3S
(2S,5R,6S)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Diphenylmethyl Ester (2S,5R,6S)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Diphenylmethyl Ester 74189-25-6 C21H20BrNO3S
Trelagliptin Impurity 5 Trelagliptin Impurity 5 2087874-92-6 C22H24FN5O5
9H-Purin-6-amine, 9-beta-D-arabinofuranosyl-2-methoxy- 9H-Purin-6-amine, 9-beta-D-arabinofuranosyl-2-methoxy- 51742-84-8 C11H15N5O5
2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 1-oxide 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid 1-oxide 2418591-42-9 C16H16N2O4S
(E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE (E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE 137131-09-0 C6H10BrNO
(E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE (E)-4-BROMO-N,N-DIMETHYLBUT-2-ENAMIDE 137131-09-0 C6H10BrNO
Almotriptan Impurity 1 Almotriptan Impurity 1 334981-13-4 C17H25N3O3S
Almotriptan Impurity 1 Almotriptan Impurity 1 334981-13-4 C17H25N3O3S
Amlodipine Impurity 33 Amlodipine Impurity 33 C26H31ClN2O8S
Erlotinib Impurity 36 HCl Erlotinib Impurity 36 HCl
Rasagiline Impurity 6 HCl Rasagiline Impurity 6 HCl 138911-07-6 C9H11NO
Palonosetron Impurity TM1-YA Palonosetron Impurity TM1-YA
Pitavastatin Impurity 33 Pitavastatin Impurity 33
Pralatrexate Impurity 14 Pralatrexate Impurity 14
Pitavastatin Impurity 51 Pitavastatin Impurity 51
Pitavastatin Impurity 59 Pitavastatin Impurity 59
Lenvatinib Impurity 42 Lenvatinib Impurity 42
Tazobactam Impurity 8 Tazobactam Impurity 8
Prednicarbate Impurity B Prednicarbate Impurity B
Doxofylline Impurity 13 Doxofylline Impurity 13
Afatinib impurity 46 Afatinib impurity 46
Afatinib impurity 46 Afatinib impurity 46
Canagliflozin Impurity 60 Canagliflozin Impurity 60
Canagliflozin Impurity 65 Canagliflozin Impurity 65
Rosuvastatin Impurity 75 Rosuvastatin Impurity 75
Acyclovir Impurity 11 Acyclovir Impurity 11
Selexipag Impurity 6 Selexipag Impurity 6
Cabozantinib impurity N Cabozantinib impurity N
Barcitinib impurity-09 Barcitinib impurity-09 1187594-16-6 C14H13N7
Rotigotine Impurity 6 Rotigotine Impurity 6
Olprinone Impurity 7 Olprinone Impurity 7 2236020-10-1 C9H10N2
Cilastatin Impurity 2 Cilastatin Impurity 2
Cilastatin Impurity 7 Cilastatin Impurity 7
Dabrafenib Impurity 1 Dabrafenib Impurity 1 1907654-22-1 C24H21F3N4O3S2
Trelagliptin Impurity SJ Trelagliptin Impurity SJ 2087874-94-8 C40H42F2N10O6
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