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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
5,5'-Bi-1H-benzimidazole, 6,6'-bis(difluoromethoxy)-2,2'-bis[[(3,4-dimethoxy-2-pyridinyl)methyl]thio]- 5,5'-Bi-1H-benzimidazole, 6,6'-bis(difluoromethoxy)-2,2'-bis[[(3,4-dimethoxy-2-pyridinyl)methyl]thio]- 2251784-93-5 C32H28F4N6O6S2
1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid, 4,10-bis[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid, 4,10-bis[2,3-dihydroxy-1-(hydroxymethyl)propyl]- 2514736-58-2 C20H40N4O10
Valsartan Methyl Ester N2-Trityl Analog Valsartan Methyl Ester N2-Trityl Analog 883223-10-7 C44H45N5O3
Ampicillin Impurity G Ampicillin Impurity G
N-(5-((diphenylphosphoryl)methyl)-4-(3-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide N-(5-((diphenylphosphoryl)methyl)-4-(3-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
Azacitidine Impurity EJ Azacitidine Impurity EJ
Budesonide Impurity 28 Budesonide Impurity 28
Ethanol, 2-[2-(2-methyl-4-nitro-1H-imidazol-1-yl)ethoxy]- Ethanol, 2-[2-(2-methyl-4-nitro-1H-imidazol-1-yl)ethoxy]- 19765-12-9 C8H13N3O4
Empagliflozin ortho isomer Empagliflozin ortho isomer 2452301-30-1 C23H27ClO7
(5R,6S)-6-((R)-1-hydroxyethyl)-7-oxo-3-((S)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid 4,4-dioxide (5R,6S)-6-((R)-1-hydroxyethyl)-7-oxo-3-((S)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid 4,4-dioxide
(3S,5R,6E) Rosuvastatin Calcium Salt (2:1) (3S,5R,6E) Rosuvastatin Calcium Salt (2:1) 2414245-11-5 C22H30CaFN3O6S
Englejing impurity 17 Englejing impurity 17 2452301-42-5 C23H27ClO7
Avatrombopag Impurity 35 Avatrombopag Impurity 35
2-AMINO-2'-FLUOROBENZOPHENONE 2-AMINO-2'-FLUOROBENZOPHENONE 1581-13-1 C13H10FNO
(R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2,2-dimethyl-1,2,3,4-tetrahydroisoquinolin-2-ium (R)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2,2-dimethyl-1,2,3,4-tetrahydroisoquinolin-2-ium 2480467-84-1 C28H35NO7S
5-METHOXY-2-(METHYLTHIO)BENZIMIDAZOLE 5-METHOXY-2-(METHYLTHIO)BENZIMIDAZOLE 91168-31-9 C9H10N2OS
4-METHYL-6-PYRIDIN-3-YLPYRIMIDIN-2-AMINE 4-METHYL-6-PYRIDIN-3-YLPYRIMIDIN-2-AMINE 90916-52-2 C10H10N4
1-Benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylindenemethyl)piperidine 1-Benzyl-4-(5,6-dimethoxy-1-oxoindan-2-ylindenemethyl)piperidine 120014-07-5 C24H27NO3
CLOPIDOGREL  RELATED  COMPOUND  C  (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE,  HYDROGEN SUL- FATE) CLOPIDOGREL RELATED COMPOUND C (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE, HYDROGEN SUL- FATE) 120202-71-3 C16H18ClNO6S2
ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE 66338-95-2 C6H8ClNO4
2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate 2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate C27H39NO3
Dexamethasone Impurity EP Impurity C Dexamethasone Impurity EP Impurity C
Palbociclib impurity LAAP Palbociclib impurity LAAP
(R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide (R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide C15H30N4O3
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32 1528636-07-8 C22H27ClO7
1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) 1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) C28H54N8O2
N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)- N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)-
Droxidopa Impurity 6 Droxidopa Impurity 6 90044-46-5 C16H15NO4
Osimertinib Impurity 2 DiHCl Osimertinib Impurity 2 DiHCl
Dofetilide Impurity B Dofetilide Impurity B
Sugammadex Monohydroxy Impurity Sugammadex Monohydroxy Impurity
Cyclic Macitentan quarternary salt Impurity Cyclic Macitentan quarternary salt Impurity
Lacosamide Impurity – K Lacosamide Impurity – K
Cefdinir CP Impurity I&J&K&L Cefdinir CP Impurity I&J&K&L
Valaciclovir EP Impurity O Valaciclovir EP Impurity O
Dapoxetine Impurity 41 Dapoxetine Impurity 41
Doxofylline Impurity 16 Doxofylline Impurity 16
Olopatadine Impurity 5 Olopatadine Impurity 5 55690-18-1 C17H16O5
Taladafil Impurity 38 Taladafil Impurity 38
Salbutamol impurity 41 Salbutamol impurity 41
Gadobutrol Impurity 20 Gadobutrol Impurity 20 3010287-09-6
Dapagliflozin Impurity 48 Dapagliflozin Impurity 48 2069934-29-6 C15H14Cl2O
Cilostazol Impurity I Cilostazol Impurity I
Lanthanum test solution(ChP) Lanthanum test solution(ChP)
Pramipexole DBTA Impurity Pramipexole DBTA Impurity 1821389-09-6 C7H8N2S
Amoxicillin Oxidized Impurities Amoxicillin Oxidized Impurities
Amoxicillin Oxidized Impurities Amoxicillin Oxidized Impurities
ZIDOVUDINE IMPURITY B ZIDOVUDINE IMPURITY B
(1S,4S,5S)-4-Bromo-6-oxabicyclo[3.2.1]octan-7-one (1S,4S,5S)-4-Bromo-6-oxabicyclo[3.2.1]octan-7-one 139893-81-5 C7H9BrO2
Acetamide, N-[2-hydroxy-3-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]propyl]-N-(1-methylethyl)- Acetamide, N-[2-hydroxy-3-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]propyl]-N-(1-methylethyl)- 66722-65-4 C20H33NO5
Pyrimidine, 4-bromo-6-(1-bromoethyl)-5-fluoro- Pyrimidine, 4-bromo-6-(1-bromoethyl)-5-fluoro- 1307315-02-1 C6H5Br2FN2
Crisaborole Impurity 16 Crisaborole Impurity 16 2268785-42-6 C14H10BNO3
guanidine guanidine 113-00-8 CH5N3
tert-Butyl (E)-3,5-Dihydroxy-7-[3'-(4 tert-Butyl (E)-3,5-Dihydroxy-7-[3'-(4"-fluorophenyl)-1'-methylethylindol-2'-yl)hept-6-enoate 194934-96-8 C28H34FNO4
1-(2-amino-4,5-dimethoxyphenyl)ethan-1-one 1-(2-amino-4,5-dimethoxyphenyl)ethan-1-one 1071574-51-0 C10H13NO3
(+)-epipinoresinol-4-O-β-D-glucoside (+)-epipinoresinol-4-O-β-D-glucoside 74983-66-7 C26H32O11
2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylthio-1H-benzimidazole 2-[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methylthio-1H-benzimidazole 103577-40-8 C16H14F3N3OS
Ethyl (3E)-3-(2-phenylhydrazin-1-ylidene)butanoate Ethyl (3E)-3-(2-phenylhydrazin-1-ylidene)butanoate 6078-46-2 C12H16N2O2
1-(5,6-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(5,6-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1824506-44-6 C12H15N
(S)-4-(4-((3-amino-2-hydroxypropyl)amino)phenyl)morpholin-3-one hydrochloride (S)-4-(4-((3-amino-2-hydroxypropyl)amino)phenyl)morpholin-3-one hydrochloride 1403383-55-0 C13H20ClN3O3
Terbutaline  Impurity Terbutaline Impurity 882066-15-1 C33H35NO3.H2O4S
Bis(4-fluorobenzyl)aMine Bis(4-fluorobenzyl)aMine 646051-52-7 C14H13F2N
2-(2-butyl-4-methyl-1-((2'-(1-methyl-
1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-
yl)methyl)-6-oxo-1,6-
dihydropyrimidin-5-yl)-N,Ndimethylethanethioamide
2-(2-butyl-4-methyl-1-((2'-(2-methyl-
2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-
yl)methyl)-6-oxo-1,6-
dihydropyri 2-(2-butyl-4-methyl-1-((2'-(1-methyl- 1H-tetrazol-5-yl)-[1,1'-biphenyl]-4- yl)methyl)-6-oxo-1,6- dihydropyrimidin-5-yl)-N,Ndimethylethanethioamide 2-(2-butyl-4-methyl-1-((2'-(2-methyl- 2H-tetrazol-5-yl)-[1,1'-biphenyl]-4- yl)methyl)-6-oxo-1,6- dihydropyri
ethyl 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylate ethyl 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-hydroxy-4-oxo-1,4-dihydroquinoline-3-carboxylate C22H26FN3O4
Matairesinol monoglucoside Matairesinol monoglucoside 34446-06-5 C26H32O11
Apremilast Apremilast 1384967-20-7 C20H20N2O7S
Pramipexole Impurity 30 Pramipexole Impurity 30 1802051-36-0 C13H24ClN3S
NZWJKTHFNLHUJO-NWZSJJIMSA-N NZWJKTHFNLHUJO-NWZSJJIMSA-N 1422954-12-8 C22H26FN3O5S
LAT-NET LAT-NET 607351-44-0 C25H39NO4
N,N-(ethane-1,2-diyl)bis(4-methyl-N-(3-((4-methylphenyl)sulfonamido)propyl)benzenesulfonamide) N,N-(ethane-1,2-diyl)bis(4-methyl-N-(3-((4-methylphenyl)sulfonamido)propyl)benzenesulfonamide) 74676-47-4 C36H46N4O8S4
L-GLUCONO-1,5-LACTONE L-GLUCONO-1,5-LACTONE 52153-09-0 C6H10O6
C-Desmethyl Atenolol C-Desmethyl Atenolol 1797116-92-7 C13H20N2O3
Arthromerin B Arthromerin B 31049-08-8 C21H22O11
Losartan Impurity 7 Losartan Impurity 7 358685-13-9 C33H24Br2N4
Fenofibric Acid 1-Carboxyl-1-methylethyl Ester Fenofibric Acid 1-Carboxyl-1-methylethyl Ester 1797121-54-0 C21H21ClO6
2-Chloro-4'-fluorobenzophenone 2-Chloro-4'-fluorobenzophenone 1806-23-1 C13H8ClFO
1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole 1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole 165115-83-3 C21H21F2N3O2
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid 855661-71-1 C21H24FN3O4
4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers) 4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers) 748817-01-8
Iopamidol Impurity K Iopamidol Impurity K 1788899-70-6 C17H23I2N3O8
N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide 87864-08-2 C16H21N3O2
5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid 5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid 1883595-37-6 C16H11FN2O4S
Ritonavir EP Impurity B Ritonavir EP Impurity B 765875-58-9 C28H36N4O4S
2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE 61698-76-8 C11H15NO4
TERBUTALINE IMPURITY C TERBUTALINE IMPURITY C 139508-58-0 C12H17NO3
4-(3,4-dichlorophenyl)-N-methyl-3,4-dihydro-2H-naphthalen-1-imine oxide 4-(3,4-dichlorophenyl)-N-methyl-3,4-dihydro-2H-naphthalen-1-imine oxide 209473-00-7 C17H15Cl2NO
Tazobactam Impurity EBT Tazobactam Impurity EBT
Mixture of Cefoxitin Impurities E&F Mixture of Cefoxitin Impurities E&F
Faropenem Degradation Impurity 4 Faropenem Degradation Impurity 4
7-(2-hydroxy-1,1-dimethoxypropyl)-5H-chromeno[2,3-b]pyridin-5-ol 7-(2-hydroxy-1,1-dimethoxypropyl)-5H-chromeno[2,3-b]pyridin-5-ol
2-chloro-1-(5-methoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one 2-chloro-1-(5-methoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
Oxacillin Impurity 3 Oxacillin Impurity 3 21106-64-9 C19H18ClN3O5S
Latanoprost Impurity 3 Latanoprost Impurity 3 2278245-92-2 C27H41BrO5
Ethyl 2-(2-Iodoethoxy)acetate Ethyl 2-(2-Iodoethoxy)acetate 56703-25-4 C6H11IO3
Spectinomycin EP Impurity C Spectinomycin EP Impurity C 63393-23-7 C14H26N2O7
Butyphthalide impurity 53 Butyphthalide impurity 53
6,8-DIBROMO-3-CYCLOHEXYL-3,4-DIHYDRO-2(1H)-QUINAZOLINONE 6,8-DIBROMO-3-CYCLOHEXYL-3,4-DIHYDRO-2(1H)-QUINAZOLINONE 21237-84-3 C14H16Br2N2O
DESTHIAZOLYLMETHYL RITONAVIR DESTHIAZOLYLMETHYL RITONAVIR 256328-82-2 C33H43N5O4S
S-DIDEMETHYL CITALOPRAM S-DIDEMETHYL CITALOPRAM 166037-78-1 C18H17FN2O
METHOTREXATE DIMETHYL ESTER METHOTREXATE DIMETHYL ESTER 34378-65-9 C22H26N8O5
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