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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
Nintedanib impurity G Nintedanib impurity G 894783-61-0 C30H31N5O4
3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 1010818-93-5 C27H34N2O2
Febuxostat impurity 36 Febuxostat impurity 36 1805770-40-4 C12H12N2O
N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide 2031255-27-1 C28H26N6O3
4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one C8H11FN3O4S-
Anastrozole Impurity 3 Anastrozole Impurity 3
Cephalexin Impurity 4 Cephalexin Impurity 4 C16H17N3O4S
Rivaroxaban Impurity 42 Rivaroxaban Impurity 42
(R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid (R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid 1422514-05-3 C22H26FN3O6S
Atorvastatin 2-Fluoro t-Butyl Ester Atorvastatin 2-Fluoro t-Butyl Ester 1099474-28-8 C40H47FN2O5
Cabozantinib Impurity C Cabozantinib Impurity C
(3R,4R)-N,4-dimethyl-piperidin-3-amine (3R,4R)-N,4-dimethyl-piperidin-3-amine 1354469-76-3 C7H16N2
4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 952518-97-7 C9H7N5
5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 881676-90-0 C16H12N2O3S
3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 100332-12-5 C13H18FNO
r-Cytidine r-Cytidine 13913-16-1 C9H13N3O5
Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- 168167-48-4 C7H7Cl2N
(S)-PYRROLIDINE-2-CARBONITRILE (S)-PYRROLIDINE-2-CARBONITRILE 204387-53-1 C5H8N2
2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID 2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID 886501-78-6 C11H9NO3S
(3R,5R)-Fluvastatin Sodium Salt (3R,5R)-Fluvastatin Sodium Salt 194934-99-1 C24H27FNNaO4
Orlistat Dihydropyranone Impurity Orlistat Dihydropyranone Impurity 130676-64-1 C22H40O2
2-Methyl-4-nitro-1H-imidazole-1-acetic acid 2-Methyl-4-nitro-1H-imidazole-1-acetic acid 16230-87-8 C6H7N3O4
Benzofuran-5-carboxylic acid Benzofuran-5-carboxylic acid 90721-27-0 C9H6O3
7-Chloro-1,6,7,8-tetradeoxy-6-[[[(2S)-1-methyl-4β-propyl-2α-pyrrolidinyl]carbonyl]amino]-1-(methylsulfinyl)-α-L-threo-D-galacto-octopyranose 7-Chloro-1,6,7,8-tetradeoxy-6-[[[(2S)-1-methyl-4β-propyl-2α-pyrrolidinyl]carbonyl]amino]-1-(methylsulfinyl)-α-L-threo-D-galacto-octopyranose 22431-46-5 C18H33ClN2O6S
2-(Propylthio)-4(1H)-pyrimidinone 2-(Propylthio)-4(1H)-pyrimidinone 54460-95-6 C7H10N2OS
BROMOSULBACTAM BROMOSULBACTAM 75527-87-6 C8H10BrNO5S
1-(CHLOROACETYL)-L-PROLINE METHYL ESTER 1-(CHLOROACETYL)-L-PROLINE METHYL ESTER 38074-72-5 C8H12ClNO3
1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID 1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID 96053-48-4 C12H20N2O3
1-(3-PYRIDYL)ETHAN-1-ONE OXIME 1-(3-PYRIDYL)ETHAN-1-ONE OXIME 5973-83-1 C7H8N2O
1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride 1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride 107049-57-0 C14H24Cl2N2O3
Sitagliptin N-Sulfate Sitagliptin N-Sulfate 940002-57-3 C16H15F6N5O4S
1-Oxo Mirtazapine (Mirtazapine Impurity C) 1-Oxo Mirtazapine (Mirtazapine Impurity C) 191546-96-0 C17H17N3O
(3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone (3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone 68711-40-0 C22H42O3
N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E) N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E) 50295-20-0 C13H21ClN2O
ent-Cinacalcet Hydrochloride ent-Cinacalcet Hydrochloride 694495-47-1 C22H22F3N
Nsc529487 Nsc529487 3310-47-2 C9H13N3O6
Oxathiolan 5fu-.B. Oxathiolan 5fu-.B. 145986-11-4 C8H9FN2O4S
Decarboxy Enrofloxacin Decarboxy Enrofloxacin 131775-99-0 C18H22FN3O
Desethanol Dipyridamole Desethanol Dipyridamole 1176886-12-6 C22H36N8O3
2’’-Desethyl-2’’-vinyl Simvastatin 2’’-Desethyl-2’’-vinyl Simvastatin 1449248-72-9 C25H36O5
1,2-Dihydro Dexamethasone 1,2-Dihydro Dexamethasone 426-17-5 C22H31FO5
Lamotrigine N2-Oxide Lamotrigine N2-Oxide 136565-76-9 C9H7Cl2N5O
4-[3-(Methylamino)-1-(2-thienyl)propyl]- 4-[3-(Methylamino)-1-(2-thienyl)propyl]- 949096-01-9 C18H20BrNOS
N-Isopropyl Carvedilol N-Isopropyl Carvedilol 1246819-01-1 C27H32N2O4
5-Oxo Atorvastatin 5-Oxo Atorvastatin 1391052-82-6 C33H33FN2O5
1-Methyl-12-thioxopyrido[1,2,3,4]imidazole-[1,2-a]benzimidazole-2(12H)-one 1-Methyl-12-thioxopyrido[1,2,3,4]imidazole-[1,2-a]benzimidazole-2(12H)-one 1246819-06-6 C14H9N3OS
Quetiapine Hydroxy Impurity Quetiapine Hydroxy Impurity 329216-67-3 C19H21N3OS
7-[4-(2-Piperidinyl)ethoxy]benzoyl Raloxifene 
(Raloxifene Impurity) 7-[4-(2-Piperidinyl)ethoxy]benzoyl Raloxifene (Raloxifene Impurity) 1159977-58-8 C42H44N2O6S
rac N-Demethyl Promethazine Hydrochloride rac N-Demethyl Promethazine Hydrochloride 60113-77-1 C16H19ClN2S
Lincomycin B Hydrochloride Lincomycin B Hydrochloride 11021-35-5 C17H33ClN2O6S
Flucloxacillin impurity C Flucloxacillin impurity C
1-[2-amino-1-(4-hydroxyphenyl)ethyl]cyclohexanol 1-[2-amino-1-(4-hydroxyphenyl)ethyl]cyclohexanol 149289-29-2 C14H21NO2
(2E)-3-(Dimethylamino)-1-(3-pyridyl)prop-2-en-1-one (2E)-3-(Dimethylamino)-1-(3-pyridyl)prop-2-en-1-one 123367-26-0 C10H12N2O
5-(2R)-2-Oxiranyl-8-benzyloxy-2(1H)-quinolinone 5-(2R)-2-Oxiranyl-8-benzyloxy-2(1H)-quinolinone 173140-90-4 C18H15NO3
Methyl-5-chlorothiophene-2-carboxylate Methyl-5-chlorothiophene-2-carboxylate 35475-03-7 C6H5ClO2S
3-Dechloro Sertraline Hydrochloride 3-Dechloro Sertraline Hydrochloride 79646-00-7 C17H19Cl2N
7-DeMethyl Ivabradine 7-DeMethyl Ivabradine 304462-60-0 C26H34N2O5
8-Dechloro-9-chloro Loratadine 8-Dechloro-9-chloro Loratadine 109537-11-3 C22H23ClN2O2
Acyclovir N-Ethyl-L-valinate Hydrochloride Acyclovir N-Ethyl-L-valinate Hydrochloride 1346617-49-9 C15H25ClN6O4
AMikacin B AMikacin B 48237-20-3 C22H44N6O12
Carboxy Gliclazide Carboxy Gliclazide 38173-52-3 C15H19N3O5S
Dehydro RifaxiMin Dehydro RifaxiMin 80621-76-7 C43H49N3O11
N,N'-Desethylene Levofloxacin Hydrochloride N,N'-Desethylene Levofloxacin Hydrochloride 151250-76-9 C16H18FN3O4
rac 3-Deacetyl-3-butanoyl Acebutolol Hydrochloride rac 3-Deacetyl-3-butanoyl Acebutolol Hydrochloride 57898-71-2 C20H33ClN2O4
rac Deoxy-O-desMethyl Venlafaxine rac Deoxy-O-desMethyl Venlafaxine 1346605-18-2 C16H25NO
2-Keto ZolpideM 2-Keto ZolpideM 400038-68-8 C19H19N3O2
N-ForMyl Oxcarbazepine N-ForMyl Oxcarbazepine 1346601-76-0 C16H12N2O3
OseltaMivir Acid Methyl Ester OseltaMivir Acid Methyl Ester 208720-71-2 C15H26N2O4
2'-[(1E)-2-[4-[[(2-carboxyethyl)aMino]carbonyl]phenyl]diazenyl] Balsalazide 2'-[(1E)-2-[4-[[(2-carboxyethyl)aMino]carbonyl]phenyl]diazenyl] Balsalazide 1346606-53-8 C27H24N6O9
7β-Fulvestrant 7β-Fulvestrant 407577-53-1 C32H47F5O3S
1,3-Di-HABA KanaMycin A 1,3-Di-HABA KanaMycin A 927821-99-6 C26H50N6O15
Dapagliflozin Tetraacetate Dapagliflozin Tetraacetate 461432-25-7 C29H33ClO10
Dantrolene Related Compound B (50 mg) (5-(4-nitrophenyl)-2-furaldehyde-(2-carboxymethyl) semicarbazone) Dantrolene Related Compound B (50 mg) (5-(4-nitrophenyl)-2-furaldehyde-(2-carboxymethyl) semicarbazone) 57268-33-4 C14H12N4O6
Doxazosin Related Compound F (15 mg) (N,N'-bis(1,4-benzodioxane-2-carbonyl)piperazine) Doxazosin Related Compound F (15 mg) (N,N'-bis(1,4-benzodioxane-2-carbonyl)piperazine) 617677-53-9 C22H22N2O6
Verapamil Related Compound A (50 mg) (3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile monohydrochloride) Verapamil Related Compound A (50 mg) (3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile monohydrochloride) 67775-97-7 C17H27ClN2O2
Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4R)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4R)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- 1255529-23-7 C24H30ClN7O4S
(1S,2S,3R,5S)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 2096989-56-7 C23H28F2N6O4S
Fosaprepitant iMpurity Fosaprepitant iMpurity
Apixaban iMpurity 1 Apixaban iMpurity 1
Azilsartan iMpurity H Azilsartan iMpurity H
Azilsartan iMpurity M Azilsartan iMpurity M
bortezoMib iMpurity F bortezoMib iMpurity F
cefoxitin iMpurity A cefoxitin iMpurity A
3-Morpholinone, 4-(2-aMinophenyl)- 3-Morpholinone, 4-(2-aMinophenyl)- 1082588-73-5 C10H12N2O2
(R)-N-(1-(naphthalen-1-yl)ethyl)-3-(4-(trifluoroMethyl)phenyl)propan-1-aMine (R)-N-(1-(naphthalen-1-yl)ethyl)-3-(4-(trifluoroMethyl)phenyl)propan-1-aMine 1428185-71-0 C22H22F3N
1-Piperidinepropanenitrile, 4-Methyl-3-(Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-ylaMino)-β-oxo- 1-Piperidinepropanenitrile, 4-Methyl-3-(Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-ylaMino)-β-oxo- 344418-92-4 C16H20N6O
Erlotinib impurity A Erlotinib impurity A 183321-85-9 C21H20ClN3O3
1,3-Dioxane-4,6-dione, 5-[[(3,4-diMethoxyphenyl)aMino]Methylene]-2,2-diMethyl- 1,3-Dioxane-4,6-dione, 5-[[(3,4-diMethoxyphenyl)aMino]Methylene]-2,2-diMethyl- 213699-53-7 C15H17NO6
(2R,3R)-2-[(1S)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine hydrochloride (2R,3R)-2-[(1S)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine hydrochloride 1333998-21-2 C20H19ClF7NO2
Budesonide iMpurity Budesonide iMpurity 192057-49-1 C24H32O6
dextroMethorphan iMpurity dextroMethorphan iMpurity
Fluticasone IMpurity Fluticasone IMpurity 397864-58-3 C27H30F2O6S
Valdecoxib iMpurity Valdecoxib iMpurity
Fluconazole IMpurity-H Fluconazole IMpurity-H
Retigabine Dihydrochloride Impurity Retigabine Dihydrochloride Impurity 1432063-93-8 C16H19ClFN3O2
Adrenaline IMpurity F Adrenaline IMpurity F 78995-75-2 C9H13NO5S
Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-Benzenediacetic acid) Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-Benzenediacetic acid) 1338800-81-9 C17H21N3O4
Apixaban IMpurity 4 (BMS-728626-01) Apixaban IMpurity 4 (BMS-728626-01) 1801881-22-0 C27H28N4O5
AtracuriuM IMpurity C1 (trans-Monoacrylate) AtracuriuM IMpurity C1 (trans-Monoacrylate)
AzithroMycin IMpurity C AzithroMycin IMpurity C
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