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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
Tofacitinib Related Compound 16 Tofacitinib Related Compound 16 2183519-70-0 C15H23N5
Vortioxetine Impurity 8 Vortioxetine Impurity 8
Erlotinib Impurity 21 Erlotinib Impurity 21
Fluvastatin EP Impurity C Fluvastatin EP Impurity C 779995-42-5 C24H26FNO4
Oseltamivir Impurity 17 Oseltamivir Impurity 17 2413185-88-1 C14H22O4
Topiroxostat Impurity 15 Topiroxostat Impurity 15
Teneligliptin Impurity 10 Di-Trifluoroacetate Teneligliptin Impurity 10 Di-Trifluoroacetate
Posaconazole iMpurity 68 Posaconazole iMpurity 68
Erlotinib Hydrochloride iMpurity 50 Erlotinib Hydrochloride iMpurity 50
(S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate (S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate 1213269-49-8 C14H11F2NO4
Vonoprazan Impurity U3 Vonoprazan Impurity U3
Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate 137211-63-3 C17H22ClN3O4
Cefonicid Impurity 1 Cefonicid Impurity 1
1589503-93-4 1589503-93-4 1589503-93-4 C27H24F2N6O3S
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
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
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
TERBUTALINE IMPURITY C TERBUTALINE IMPURITY C 139508-58-0 C12H17NO3
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
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
1-Ethyl-2-[[(2-methoxy-5-sulphamoyl 1-Ethyl-2-[[(2-methoxy-5-sulphamoyl
2-(4-Bromo-3-formylphenoxy)-benzonitrile 2-(4-Bromo-3-formylphenoxy)-benzonitrile 1160182-46-6 C14H8BrNO2
Carbetocin S-Oxide I Carbetocin S-Oxide I
Dolutegravir Impurity 15 Dolutegravir Impurity 15
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
4-(DICHLOROMETHYL)BENZONITRILE 4-(DICHLOROMETHYL)BENZONITRILE 74231-65-5 C8H5Cl2N
3-(4-FLUORO-PHENYL)-1-ISOPROPYL-1H-INDOLE-2-CARBALDEHYDE 3-(4-FLUORO-PHENYL)-1-ISOPROPYL-1H-INDOLE-2-CARBALDEHYDE 101125-34-2 C18H16FNO
3,4-DIMETHOXY-2-HYDROXYBENZALDEHYDE 3,4-DIMETHOXY-2-HYDROXYBENZALDEHYDE 19283-70-6 C9H10O4
Sugammadex sodium Org199129-1 Impurity Sugammadex sodium Org199129-1 Impurity
Sugammadex sodium Impurity 41 Sugammadex sodium Impurity 41
Apixaban Impurity 51 Apixaban Impurity 51 1620494-29-2 C33H32N4O5
4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide 2242749-01-3 C16H14N2O3S
Cefazolin Impurity EP-I Cefazolin Impurity EP-I
Cabozantinib impurity 42 Cabozantinib impurity 42
Cabozantinib impurity 55 Cabozantinib impurity 55
Canagliflozin Impurity 68 Canagliflozin Impurity 68
Dapoxetine impurity 51 Dapoxetine impurity 51
Doxofylline Impurity 20 Doxofylline Impurity 20
Dapoxetine impurity 64 Dapoxetine impurity 64
Dapoxetine impurity 58 Dapoxetine impurity 58
1-(4-NITRO-PHENYL)-1H-PYRIDIN-2-ONE 1-(4-NITRO-PHENYL)-1H-PYRIDIN-2-ONE 53427-97-7 C11H8N2O3
PeraMpanel PeraMpanel 380919-67-5 C23H15N3O2
Empagliflozin Impurity 86 Empagliflozin Impurity 86
Olopatadine Impurity 11 HBr Olopatadine Impurity 11 HBr 4174-84-9 C21H24Br2NP
Iohexol Impurity P Iohexol Impurity P
Avibactam sodium Impurity CEA Avibactam sodium Impurity CEA
Sulbactam Impurity 2 Sulbactam Impurity 2 111790-24-0 C8H13NO6S
Vortioxetine Impurity 8 HCl Vortioxetine Impurity 8 HCl 2137722-14-4 C18H23ClN2S
Relugolix Impurity 1 Relugolix Impurity 1
Oseltamivir Diastereomer III HCl Oseltamivir Diastereomer III HCl 2413185-95-0 C16H28N2O4
Rocuronium bromide impurity (3,16,17-triol) Rocuronium bromide impurity (3,16,17-triol) C23H39NO4
4-(4-amino-3-chlorophenoxy)-7-methoxyquinoline-6-carboxylic acid 4-(4-amino-3-chlorophenoxy)-7-methoxyquinoline-6-carboxylic acid C17H13ClN2O4
Ornidazole Impurity 26 Ornidazole Impurity 26
Pitavastatin Impurity 73 Pitavastatin Impurity 73
Furosemide Impurity 24 Furosemide Impurity 24
Brivaracetam Impurity 34 Brivaracetam Impurity 34
1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-(((3-(hydroxymethyl)pyridin-2-yl)(methyl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride 1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-(((3-(hydroxymethyl)pyridin-2-yl)(methyl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium chloride
Amoxicillin Impurity ABCDEFGHIJKLM Amoxicillin Impurity ABCDEFGHIJKLM
Amoxicillin Impurity ABCDEFGHIJKLM Amoxicillin Impurity ABCDEFGHIJKLM
β-D-Glucopyranoside, [[(3R,3aS,6S,6aR)-tetrahydro-3a-hydroxy-1H,3H-furo[3,4-c]furan-3,6-diyl]bis(2-methoxy-4,1-phenylene)]bis β-D-Glucopyranoside, [[(3R,3aS,6S,6aR)-tetrahydro-3a-hydroxy-1H,3H-furo[3,4-c]furan-3,6-diyl]bis(2-methoxy-4,1-phenylene)]bis 112747-99-6 C32H42O17
1H-1,2,4-Triazole-1-propanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)- 1H-1,2,4-Triazole-1-propanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)- 1222655-38-0 C14H14F2N6O
3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, (αS,3S)- 3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, (αS,3S)- 741267-75-4 C12H20N2O5
Topiroxostat Impurity 44 Topiroxostat Impurity 44 1824131-48-7 C7H6N4O
Fexofenadine Impurity 12 Fexofenadine Impurity 12 1010812-98-2 C32H37NO4
2,2'-(oxybis((2-chloro-5-iodophenyl)methylene))diphenol 2,2'-(oxybis((2-chloro-5-iodophenyl)methylene))diphenol C26H18Cl2I2O3
Gliclazide Impurity 6 Gliclazide Impurity 6 1207714-41-7 C8H10N2O3S
Phenol, 4,4'-(4-pyridinylmethylene)bis- Phenol, 4,4'-(4-pyridinylmethylene)bis- 109810-81-3 C18H15NO2
Ropivacaine Impurity 50 Ropivacaine Impurity 50
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