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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
Lercanidipine Impurity 25 Lercanidipine Impurity 25 100427-22-3 C36H41N3O6
Oseltamivir Impurity 30 Oseltamivir Impurity 30
Pitavastatin Impurity 25 Pitavastatin Impurity 25 1356998-79-2 C19H16FN
Rocuronium Bromide Impurity 16 Rocuronium Bromide Impurity 16
Rocuronium Bromide Impurity 25 Rocuronium Bromide Impurity 25
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
Cefmetazole Lactone Cefmetazole Lactone 70993-70-3 C13H13N3O5S2
Canagliflozin Impurity 19 Canagliflozin Impurity 19
Canagliflozin Impurity 24 Canagliflozin Impurity 24
Carfilzomib Impurity 5 Carfilzomib Impurity 5
Dolutegravir Impurity 6 Dolutegravir Impurity 6 1357289-29-2 C20H19F2N3O5
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
Tofacitinib Impurity K Tofacitinib Impurity K
N-(3-chloro-4-fluorophenyl)-7 -methoxy-6-(3-morpholinopropoxy)-N-(3-morpholinopropyl)quinazolin-4-amine N-(3-chloro-4-fluorophenyl)-7 -methoxy-6-(3-morpholinopropoxy)-N-(3-morpholinopropyl)quinazolin-4-amine 1502829-45-9 C29H37ClFN5O4
5-(hydroxymethyl)-1,2-dihydro-1,2,4-triazol-3-one 5-(hydroxymethyl)-1,2-dihydro-1,2,4-triazol-3-one 24021-90-7 C3H5N3O2
( 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butylester ) ( 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butylester ) 475084-96-9 C29H37N3O3
N-(4-Hydroxymethylbenzyl) Cyclam N-(4-Hydroxymethylbenzyl) Cyclam 176252-20-3 C18H32N4O
Alvimopan Impurity 3 Alvimopan Impurity 3
Nicergoline Impurity G Nicergoline Impurity G
Isavuconazole Impurity 1 Isavuconazole Impurity 1 2069200-13-9 C13H12F2N4O
Sofosbuvir Impurity23 Sofosbuvir Impurity23
Tacrolimus Impurity 1 Tacrolimus Impurity 1
Bisoprolol EP Impurity F Bisoprolol EP Impurity F 1798418-82-2 C18H31NO4
Pantoprazole EP Impurity F Pantoprazole EP Impurity F 721924-06-7 C17H17F2N3O4S
Rosuvastatin EP Impurity E Rosuvastatin EP Impurity E
Tiotropium EP Impurity C Tiotropium EP Impurity C 136310-95-7 C19H22NO3S2.Br
Febuxostat Impurity 22 Febuxostat Impurity 22
Istradefylline Impurity C Istradefylline Impurity C
Everolimus O-Ethyl Impurity Everolimus O-Ethyl Impurity 1704711-12-5 C54H85NO14
(3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine (3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-1-methyl-4-phenylpiperidine 324023-99-6 C20H23NO3
Solifenacin Impurity 4(Solifenacin EP Impurity H) Solifenacin Impurity 4(Solifenacin EP Impurity H) 732228-02-3 C23H26N2O2
849217-77-2 849217-77-2 849217-77-2 C22H20N2O6
1-Piperidinepropanoic acid, 4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-, ethyl ester, (3R,4R)- 1-Piperidinepropanoic acid, 4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-, ethyl ester, (3R,4R)- 1675248-18-6 C18H25N5O3
Amlodipine iMpurity L Amlodipine iMpurity L 1821498-25-2 C17H19ClN2O5
(6R,7R)-7-[(2,2-dimethylpropanoyl)amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (6R,7R)-7-[(2,2-dimethylpropanoyl)amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 2384108-14-7 C16H20N4O4S3
methyl (41R,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 58000-63-8 C21H26N2O3
(S)-ethyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate (S)-ethyl 2-(((S)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate 1392015-05-2 C17H15F5NO5P
N-(2-(dimethylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide N-(2-(dimethylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide 2044702-39-6 C25H26N6O2
3-(2-cyclopentylidene-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide 3-(2-cyclopentylidene-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide C19H26BrNO2
Apixaban Impurity 16 Apixaban Impurity 16 1619934-76-7 C31H37N5O6
Cephalexin Impurity 3 Cephalexin Impurity 3 C16H17N3O4S
(6R,7R)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-pivalamido-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (6R,7R)-3-(((5-methyl-1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-7-pivalamido-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 1798390-48-3 C16H20N4O4S3
(S)-ethyl 3-((R)-5-oxopyrrolidine-2-carbonyl)thiazolidine-4-carboxylate(DD) (S)-ethyl 3-((R)-5-oxopyrrolidine-2-carbonyl)thiazolidine-4-carboxylate(DD)
Lincomycin EP Impurity B Lincomycin EP Impurity B 37744-65-3 C18H32N2O6S
Roxithromycin EP Impurity D Roxithromycin EP Impurity D 134931-00-3 C41H76N2O15
2-(pentan-3-yloxy)acetaldehyde 2-(pentan-3-yloxy)acetaldehyde 1141364-90-0 C7H14O2
Abiraterone Impurity 10 Abiraterone Impurity 10 165334-69-0 C26H33NO2
Cabozantinib Impurity B Cabozantinib Impurity B
(R)-5-(2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-amine (R)-5-(2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-amine 1223404-88-3 C16H15F2N5
Pinocembrin 7-O-beta-D-glucoside Pinocembrin 7-O-beta-D-glucoside 75829-43-5 C21H22O9
Ceftazidime Ep Impurity H Ceftazidime Ep Impurity H 1354396-23-8 C23H24N6O7S2
Parecoxib Sodium Impurity 14 Parecoxib Sodium Impurity 14 1709956-89-7 C19H18N2O4S
Benzoic acid, 2-[(methylamino)sulfonyl]- Benzoic acid, 2-[(methylamino)sulfonyl]- 125372-22-7 C8H9NO4S
1-Piperazineethanol,4-[(2-chlorophenyl)(3-chlorophenyl)methyl]-, hydrochloride (1:2) 1-Piperazineethanol,4-[(2-chlorophenyl)(3-chlorophenyl)methyl]-, hydrochloride (1:2) 126517-38-2 C19H24Cl4N2O
Benzene,1-ethoxy-4-(phenylmethyl)- Benzene,1-ethoxy-4-(phenylmethyl)- 35672-52-7 C15H16O
Donepezil  Impurity Donepezil Impurity 36159-03-2 C22H22O5
tert-Butyl 4-(4-nitropyridin-3-yl)piperazine-1-carboxylate tert-Butyl 4-(4-nitropyridin-3-yl)piperazine-1-carboxylate 1774898-55-3 C14H20N4O4
4-(2-Aminophenoxy)-N-methylpicolinamide 4-(2-Aminophenoxy)-N-methylpicolinamide 1153328-25-6 C13H13N3O2
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