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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
Atorvastatin pyrrolidone lactone Atorvastatin pyrrolidone lactone 906552-19-0 C33H33FN2O5
Cabozantinib Impurity G Cabozantinib Impurity G
Clopidogrel Impurity 10 Clopidogrel Impurity 10 C15H14ClNO2S
Dapoxetine Impurity 4 HCl Dapoxetine Impurity 4 HCl 119357-39-0 C21H23NO
Medetomidine Impurity 2 Medetomidine Impurity 2 33967-19-0 C10H14O
Tofacitinib Impurity 34 Tofacitinib Impurity 34 2459302-86-2 C19H22N8
7-Phenyl-acetamido-deacetoxy-cephalosporanic-acid 7-Phenyl-acetamido-deacetoxy-cephalosporanic-acid 27255-72-7 C16H16N2O4S
O-PROPIONYLBENZOIC ACID O-PROPIONYLBENZOIC ACID 2360-45-4 C10H10O3
(4S-cis)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester (4S-cis)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester 196085-85-5 C14H23NO4
(3S,4S,6S)-3-Hexyl-3,4,5,6-tetrahydro-4-hydroxy-6-undecyl-2H-pyran-2-one (3S,4S,6S)-3-Hexyl-3,4,5,6-tetrahydro-4-hydroxy-6-undecyl-2H-pyran-2-one 68711-33-1 C22H42O3
3-METHOXY-L-TYROSINE 3-METHOXY-L-TYROSINE 300-48-1 C10H13NO4
Triacetyl Aloe-emodin (Impurity A) Triacetyl Aloe-emodin (Impurity A) 25395-11-3 C21H16O8
2,4'-Diamino[sulfonylbisbenzene] 2,4'-Diamino[sulfonylbisbenzene] 27147-69-9 C12H12N2O2S
2-P-TOLYLOXYMETHYL-OXIRANE 2-P-TOLYLOXYMETHYL-OXIRANE 2186-24-5 C10H12O2
3-Hydroxyazobenzene 3-Hydroxyazobenzene 2437-11-8
Astragalin 7-O-β-D-glucopyranoside Astragalin 7-O-β-D-glucopyranoside 25615-14-9 C27H30O16
4-(5-CHLORO-2-THIENYL)-1,3-THIAZOL-2-AMINE 4-(5-CHLORO-2-THIENYL)-1,3-THIAZOL-2-AMINE 123971-45-9 C7H5ClN2S2
α,α-Dibromo-o-tolunitrile α,α-Dibromo-o-tolunitrile 655-63-0 C8H5Br2N
(S)-6-(benzyloxy)-8-(oxiran-2-yl)-2H-benzo[b][1,4]oxazin-3(4H)-one (S)-6-(benzyloxy)-8-(oxiran-2-yl)-2H-benzo[b][1,4]oxazin-3(4H)-one
Odaterol Impurity 35 Odaterol Impurity 35
7-CHLORO-1-ETHYL-6-FLUORO-4-OXO-1,4-DIHYDRO-[1,8]NAPHTHYRIDINE-3-CARBOXYLIC ACID 7-CHLORO-1-ETHYL-6-FLUORO-4-OXO-1,4-DIHYDRO-[1,8]NAPHTHYRIDINE-3-CARBOXYLIC ACID 79286-73-0 C11H8ClFN2O3
HYDRIDE-L HYDRIDE-L 41639-74-1 C18H22O4
2-Amino-4-trifluoromethoxybenzothiazole 2-Amino-4-trifluoromethoxybenzothiazole 235101-36-7 C8H5F3N2OS
7-[(4S)-4-Amino-6-azaspiro[2.4]heptan-6-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid 7-[(4S)-4-Amino-6-azaspiro[2.4]heptan-6-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid 127254-10-8 C19H18ClF2N3O3
Sitagliptin Carbamoyl -D-Glucuronide Sitagliptin Carbamoyl -D-Glucuronide 940002-59-5 C23H23F6N5O9
5-Hydroxy Desloratadine 5-Hydroxy Desloratadine 117811-12-8 C19H19ClN2O
D-Streptamine, o-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 3)-(4-amino-2-hydroxybutyryl)-2-deoxy- D-Streptamine, o-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 3)-(4-amino-2-hydroxybutyryl)-2-deoxy- 50725-24-1 C22H43N5O13
O-Benzyl Posaconazole O-Benzyl Posaconazole 170985-86-1 C44H48F2N8O4
10-trans-Atorvastatin Acetonide tert-Butyl Ester 10-trans-Atorvastatin Acetonide tert-Butyl Ester 1105067-90-0 C40H47FN2O5
3-Bromo Carbidopa 3-Bromo Carbidopa 1246819-09-9 C10H13BrN2O4
(4S,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid tert-Butyl Ester (4S,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid tert-Butyl Ester 186508-95-2 C14H23NO4
(5R)-6-Cyano-5-hydroxy-3-oxo-hexanoic Acid tert-Butyl Ester (5R)-6-Cyano-5-hydroxy-3-oxo-hexanoic Acid tert-Butyl Ester 125988-01-4 C11H17NO4
(4-Carboxy-3-ethoxy)phenyl Acetic Acid (Repaglinide Impurity) (4-Carboxy-3-ethoxy)phenyl Acetic Acid (Repaglinide Impurity) 220438-80-2 C11H12O5
2-Chloromethyl-3,5-dimethylpyridin-4-ol 2-Chloromethyl-3,5-dimethylpyridin-4-ol 220771-03-9 C8H10ClNO
(3S,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester (3S,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester 186508-94-1 C11H19NO4
2-Methyl-6-[(4-methylphenyl)sulfonyl]-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine 2-Methyl-6-[(4-methylphenyl)sulfonyl]-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine 717917-14-1 C19H19N3O2S
(1R-4S)-4-[[(1,1-dimethylethoxy)carbonyl]amino]- 2-Cyclopentene-1-carboxylic acid methyl ester (1R-4S)-4-[[(1,1-dimethylethoxy)carbonyl]amino]- 2-Cyclopentene-1-carboxylic acid methyl ester 251326-99-5 C12H19NO4
O-Isobutyryl (R)-Fesoterodine O-Isobutyryl (R)-Fesoterodine 1208313-13-6 C30H43NO4
Isopropyl Itraconazole Isopropyl Itraconazole 89848-49-7 C34H36Cl2N8O4
(R)-(-)-Ibuprofen-d3 (R)-(-)-Ibuprofen-d3 121702-86-1 C13H18O2
(S,R,S,S)-Orlistat (S,R,S,S)-Orlistat 111466-63-8 C29H53NO5
N-Trityl Candesartan Ethyl Ester N-Trityl Candesartan Ethyl Ester 856414-35-2 C45H38N6O3
3R,4S-4-(4-methoxyphenyl)-1-methylpiperi
dinyl] methanol 3R,4S-4-(4-methoxyphenyl)-1-methylpiperi dinyl] methanol 127017-78-1 C14H21NO2
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 188399-46-4 C12H15N5O3
4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 141650-31-9 C19H22N2O5
Valsartan cyano analog methyl ester Valsartan cyano analog methyl ester 137863-90-2 C25H30N2O3
(8S)-2-BroMo α-Ergocryptine (8S)-2-BroMo α-Ergocryptine 65700-36-9 C32H40BrN5O5
3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 217636-47-0 C17H15ClO3
5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 53885-64-6 C14H11Cl2NS
ClarithroMycin 9-OxiMe ClarithroMycin 9-OxiMe 103450-87-9 C38H70N2O13
Desloratadine N-Hydroxypiperidine Desloratadine N-Hydroxypiperidine 1193725-73-3 C19H19ClN2O
O-DesMethyl Venlafaxine Cyclic IMpurity O-DesMethyl Venlafaxine Cyclic IMpurity 1346601-55-5 C16H23NO2
rac-cis-2,3-Dichloro Sertraline Hydrochloride rac-cis-2,3-Dichloro Sertraline Hydrochloride 1198084-29-5 C17H18Cl3N
11β-Hydroperoxy Dienogest 11β-Hydroperoxy Dienogest 106111-43-7 C20H25NO4
Acetamide, N-(4-hydroxyphenyl)-N-nitroso- Acetamide, N-(4-hydroxyphenyl)-N-nitroso- 146897-60-1 C8H8N2O3
(5-(2-fluorophenyl)-1H-pyrrol-3-yl)methanamine hydrochloride (5-(2-fluorophenyl)-1H-pyrrol-3-yl)methanamine hydrochloride
Rocuronium Bromide Impurity 24 、25 Rocuronium Bromide Impurity 24 、25
Roxadustat Impurity 17 Roxadustat Impurity 17
Perospirone Impurity 20 Perospirone Impurity 20 1002359-81-0
Dolutegravir Impurity 19 Dolutegravir Impurity 19
Cephalexin Impurity I Cephalexin Impurity I
Fondaparinux sodium impurity 6 Fondaparinux sodium impurity 6
	Fondaparinux sodium impurity 2 Fondaparinux sodium impurity 2
Oxacillin sodium  Impurity I Oxacillin sodium Impurity I
Mixture of Cefoxitin  Impurity E&F Mixture of Cefoxitin Impurity E&F
Revefenacin Impurity 22 Revefenacin Impurity 22
Lasmiditan Impurity 7 Lasmiditan Impurity 7
Febuxostat impurity BAC Febuxostat impurity BAC
4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 866018-46-4 C16H14Cl2O
Lasmiditan Impurity 9 Lasmiditan Impurity 9
Letermovir Impurity 2 Letermovir Impurity 2
1H-Imidazole-2-carboxylic acid 1H-Imidazole-2-carboxylic acid 16042-25-4 C4H4N2O2
Olodaterol Impurity 19 Olodaterol Impurity 19
Ethacridine Impurity 12 Ethacridine Impurity 12
2-[4-[(2RS)-2-HYDROXY-3[(1-METHYLETHYL)AMINO]PROPOXY]PHENYL]ACETONITRILE 2-[4-[(2RS)-2-HYDROXY-3[(1-METHYLETHYL)AMINO]PROPOXY]PHENYL]ACETONITRILE 29277-73-4 C14H20N2O2
(-)-Nebivolol (-)-Nebivolol 118457-16-2 C22H25F2NO4
2-Hydroxymethyl Olanzapine 2-Hydroxymethyl Olanzapine 174756-45-7 C17H20N4OS
5-Hydroxymethyl Flucloxacillin 5-Hydroxymethyl Flucloxacillin 75524-31-1 C19H17ClFN3O6S
6-Hydroxy-5-methoxy-1-indanone 6-Hydroxy-5-methoxy-1-indanone 90843-62-2 C10H10O3
Metronidazole IMpurity (1-Methyl-4-Nitro-1H-IMidazole) Metronidazole IMpurity (1-Methyl-4-Nitro-1H-IMidazole) 143508-97-8 C2H3NO
benidipine benidipine 119009-45-9 C28H31N3O6
(S)-Phenylephrine hydrochloride (S)-Phenylephrine hydrochloride 939-38-8 C9H14ClNO2
L-erythro-3-(3,4-Dihydroxyphenyl)serine L-erythro-3-(3,4-Dihydroxyphenyl)serine 34047-62-6 C9H11NO5
Imimidistine impurity I Imimidistine impurity I
ethylmethylglycinexylidide ethylmethylglycinexylidide 74634-66-5 C13H20N2O
riboflavin 3',5'-bisphosphate riboflavin 3',5'-bisphosphate 86108-26-1 C17H22N4O12P2
Notoginsenoside FP1 Notoginsenoside FP1 1004988-73-1 C47H80O18
6 beta-hydroxycortisol 6 beta-hydroxycortisol 53-35-0 C21H30O6
16-hydroxyclarithromycin 16-hydroxyclarithromycin 124412-58-4 C38H69NO14
4-METHYL-3-[[1-OXO-2-(PROPYLAMINO)PROPYL]AMINO]-2-THIOPHENECARBOXYLIC ACID 4-METHYL-3-[[1-OXO-2-(PROPYLAMINO)PROPYL]AMINO]-2-THIOPHENECARBOXYLIC ACID 114176-52-2 C12H18N2O3S
Avatrombopag Impurity 60 (Hydrochloride) Avatrombopag Impurity 60 (Hydrochloride)
1-(4-Isobutylphenyl)ethanol 1-(4-Isobutylphenyl)ethanol 40150-92-3 C12H18O
TRIMETHYL(3-HYDROXYPHENYL)AMMONIUMIODIDE TRIMETHYL(3-HYDROXYPHENYL)AMMONIUMIODIDE 2498-27-3 C9H14INO
ACEMETACINTERT-BUTYLESTER ACEMETACINTERT-BUTYLESTER 75302-98-6 C25H26ClNO6
2-ETHYLHEXYLGLUCOPYRANOSIDE 2-ETHYLHEXYLGLUCOPYRANOSIDE 125590-73-0 C14H28O6
methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate 22032-65-1 C12H14N2O2
(5-BENZYLIDENE-4-OXO-2-THIOXO-THIAZOLIDIN-3-YL)-ACETIC ACID (5-BENZYLIDENE-4-OXO-2-THIOXO-THIAZOLIDIN-3-YL)-ACETIC ACID 82159-06-6 C12H9NO3S2
3-NITROPHENYLACETYLENE 3-NITROPHENYLACETYLENE 3034-94-4 C8H5NO2
3-(4-Methylimidazol-1-yl)-5-trifluoromethylbenzoic acid 3-(4-Methylimidazol-1-yl)-5-trifluoromethylbenzoic acid 641571-13-3 C12H9F3N2O2
3-Morpholinopropyl bromide 3-Morpholinopropyl bromide 125422-83-5 C7H14BrNO
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