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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
Puerarin-4'-O-β-D-glucopyranoside Puerarin-4'-O-β-D-glucopyranoside 117047-08-2 C27H30O14
N-Propyl-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one N-Propyl-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one 2512208-76-1 C15H21NO3
Mirabegron iMpurity Mirabegron iMpurity 1581285-26-8 C16H21ClN2
Sunitinib iMpurity Sunitinib iMpurity 356068-98-9 C12H19N3O2
(-)-DihydroapovincaMinic Acid Ethyl Ester (-)-DihydroapovincaMinic Acid Ethyl Ester 57327-92-1 C22H28N2O2
(α1S,α4S,2S,5S)-2,5-DiMethyl-3,6-dioxo-α1,α4-bis(2-phenylethyl)-1,4-piperazinediacetic Acid 1,4-Diethyl Ester (α1S,α4S,2S,5S)-2,5-DiMethyl-3,6-dioxo-α1,α4-bis(2-phenylethyl)-1,4-piperazinediacetic Acid 1,4-Diethyl Ester 151387-05-2 C30H38N2O6
[2-(4-Fluorophenyl)cyclopropyl]aMine hydrochloride [2-(4-Fluorophenyl)cyclopropyl]aMine hydrochloride 879324-66-0 C9H11ClFN
[4-(4-AMino-7-hydroxy-6-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone [4-(4-AMino-7-hydroxy-6-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone 105356-90-9 C18H23N5O4
2-(DiethylaMino)-N-(2,5-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,5-diMethylphenyl)acetaMide Hydrochloride 1012864-23-1 C14H23ClN2O
2-Keto-D-gulonic Acid Methyl Ester 2-Keto-D-gulonic Acid Methyl Ester 67776-07-2 C7H12O7
9,11-Dehydro-17α-cyanoMethyl Estradiol 9,11-Dehydro-17α-cyanoMethyl Estradiol 86153-38-0 C20H23NO2
DeMethyl Irbesartan DeMethyl Irbesartan 158778-58-6 C24H26N6O
Epiprednisolone Epiprednisolone 600-90-8 C21H28O5
δ-2-CefodiziMe (2 :1 Mixture) δ-2-CefodiziMe (2 :1 Mixture) 120533-30-4 C20H20N6O7S4
Salbutamol Acetonide Salbutamol Acetonide 54208-72-9 C16H25NO3
8-Chloro-1-methyl-6-phenyl-4H-Imidazo[1,5-a][1,4]benzodiazepine 8-Chloro-1-methyl-6-phenyl-4H-Imidazo[1,5-a][1,4]benzodiazepine 59467-86-6 C18H14ClN3
BenzeneMethanaMine, 4-ethoxy-3-Methoxy-a-[(Methylsulfonyl)Methyl]- BenzeneMethanaMine, 4-ethoxy-3-Methoxy-a-[(Methylsulfonyl)Methyl]- 885268-06-4 C12H19NO4S
Afatinib IMpurity C Afatinib IMpurity C
Flurbiprofen Impurity Flurbiprofen Impurity 64858-90-8 C17H17FO2
IMp. A (EP) as DisodiuM Salt: (4S)-2-[Carboxy[[[3-(2-chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethylthiazolidine-4-carboxylic Acid DisodiuM Salt(Penicilloic Acids of Flucloxacillin DisodiuM Salt) IMp. A (EP) as DisodiuM Salt: (4S)-2-[Carboxy[[[3-(2-chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethylthiazolidine-4-carboxylic Acid DisodiuM Salt(Penicilloic Acids of Flucloxacillin DisodiuM Salt)
the Metabolite of Ivabradine the Metabolite of Ivabradine 215935-23-2 C26H34N2O5
Acarbose 1,1-α,α-Glycoside IMpurity Acarbose 1,1-α,α-Glycoside IMpurity 610271-07-3 C25H43NO18
Acarbose 1,1-α,α-Glycoside IMpurity Acarbose 1,1-α,α-Glycoside IMpurity 610271-07-3 C25H43NO18
Des-6-[4-(2-hydroxyethyl)-1-piperazinyl]-6-chloro Dasatinib Des-6-[4-(2-hydroxyethyl)-1-piperazinyl]-6-chloro Dasatinib 910297-71-1 C16H13Cl2N5O2S
Hydroxythiovardenafil Hydroxythiovardenafil 912576-30-8 C23H32N6O4S2
(((((1-(6-aMino-9H-purin-9-yl)propan-2-yl)oxy)Methyl)phosphoryl)bis(oxy))bis(Methylene) isopropyl Methyl dicarbonate (((((1-(6-aMino-9H-purin-9-yl)propan-2-yl)oxy)Methyl)phosphoryl)bis(oxy))bis(Methylene) isopropyl Methyl dicarbonate 1246812-43-0 C17H26N5O10P
9(10H)-Acridinone, 6-aMino-2-ethoxy- 9(10H)-Acridinone, 6-aMino-2-ethoxy- 144335-20-6 C15H14N2O2
parecoxib impurity L parecoxib impurity L
Rupatadine iMpurity Rupatadine iMpurity 169253-15-0 C19H19ClN2
ceftazidiMe iMpurity C ceftazidiMe iMpurity C
pidotiMod iMpurity E pidotiMod iMpurity E 162148-16-5 C9H12N2O4S
1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-[7-(hydroxyMethyl)-7H-pyrrolo[2,3-d]pyriMidin-4-yl]-,(βR)- 1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-[7-(hydroxyMethyl)-7H-pyrrolo[2,3-d]pyriMidin-4-yl]-,(βR)- 1236033-03-6 C18H20N6O
Cyclopropanecarboxylic acid, 1-[(phenylaMino)carbonyl]- Cyclopropanecarboxylic acid, 1-[(phenylaMino)carbonyl]- 145591-80-6 C11H11NO3
3-PiperidinaMine, 1-acetyl-N,4-diMethyl-N-1H-pyrrolo[2,3-d]pyriMidin-4-yl-, (3R,4R)- (9CI) 3-PiperidinaMine, 1-acetyl-N,4-diMethyl-N-1H-pyrrolo[2,3-d]pyriMidin-4-yl-, (3R,4R)- (9CI) 477600-76-3 C15H21N5O
AzithroMycin iMpurity AzithroMycin iMpurity 194809-66-0 C37H69BN2O13
MeropeneM iMpurity MeropeneM iMpurity 96035-23-3 C15H19N3O5S
Ciprofloxacin EP IMpurity B Ciprofloxacin EP IMpurity B 93107-11-0 C17H19N3O3
Valdecoxib IMpurity-E Valdecoxib IMpurity-E 1373038-63-1 C16H11Cl2NO5S2
Afatinib IMpurity C Afatinib IMpurity C
AMisulpride IMpurity AMisulpride IMpurity 84859-26-7 C8H17NO2
Avanafil iMpurity 5 Avanafil iMpurity 5
Cefoxitin iMpurity E (R-Methoxy cefoxitin) Cefoxitin iMpurity E (R-Methoxy cefoxitin)
Desloratadine IMpurity 3 Desloratadine IMpurity 3 1346600-61-0 C19H19ClN2
DibroMo IMpurity DibroMo IMpurity 1352492-08-0 C15H12Br2O2
ErtapeneM IMpurity DIPP ErtapeneM IMpurity DIPP 220031-86-7 C18H27N2O6PS
Gefitinib IMpurity 1 Gefitinib IMpurity 1 1561173-24-7 C15H22ClN3O3
Pitavastatin Defuoro IMpurity CalciuM Salt Pitavastatin Defuoro IMpurity CalciuM Salt 1258947-30-6 C50H50CaN2O8
Solifenacin Related CoMpound 4 Succinate Solifenacin Related CoMpound 4 Succinate 862207-71-4 C27H32N2O6
TenoxicaM IMpurity E (2-Methylthieno[2,3-d]isothiazol-3(2H)-one-1,1-dioxide ) TenoxicaM IMpurity E (2-Methylthieno[2,3-d]isothiazol-3(2H)-one-1,1-dioxide ) 94040-09-2 C6H5NO3S2
(+)-(14β)-Dihydrovinpocetine (+)-(14β)-Dihydrovinpocetine 57517-54-1 C22H28N2O2
D,L-Venlafaxine-d10 Hydrochloride D,L-Venlafaxine-d10 Hydrochloride 1216539-56-8 C17H28ClNO2
Ceritinib IMpurity Ceritinib IMpurity
Melphalan IMpurity Melphalan IMpurity
1-[2-[(5-chloro-2,4-diMethylphenyl)thio]phenyl]- Piperazine 1-[2-[(5-chloro-2,4-diMethylphenyl)thio]phenyl]- Piperazine 1240670-87-4 C18H21ClN2S
Nsc249004 Nsc249004 7428-39-9 C9H13N3O5
(S)-Ethyl 2-((3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl)pentanoate ,95% (S)-Ethyl 2-((3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl)pentanoate ,95% 129970-98-5 C19H30N2O4
Exemestane Impurity A Exemestane Impurity A
(1R,3S)-1-(1,3-Benzodioxol-5-yl)-2-(2-chloroacetyl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2-(2-chloroacetyl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester 629652-44-4 C22H19ClN2O5
3-DesMorpholinyl-3-hydroxyethylaMino Gefitinib 3-DesMorpholinyl-3-hydroxyethylaMino Gefitinib 847949-56-8 C20H22ClFN4O3
4-Deschloro-4-(2-furanylMethyl)aMino FuroseMide 4-Deschloro-4-(2-furanylMethyl)aMino FuroseMide 5046-19-5 C17H17N3O6S
Cephalexin Sulfoxide Cephalexin Sulfoxide 56193-21-6 C16H17N3O5S
6α-Methyl Hydrocortisone 21-HeMisuccinate 6α-Methyl Hydrocortisone 21-HeMisuccinate 119657-85-1 C26H36O8
Hydroxy TorseMide Hydroxy TorseMide 99300-68-2 C16H20N4O4S
Hydroxy Varenicline N-Trifluoroacetate Hydroxy Varenicline N-Trifluoroacetate 357426-10-9 C15H12F3N3O2
N2-Methyl Alfuzosin Hydrochloride N2-Methyl Alfuzosin Hydrochloride 72104-34-8 C19H28ClN5O4
N2-Methyl Alfuzosin Hydrochloride N2-Methyl Alfuzosin Hydrochloride 72104-34-8 C19H28ClN5O4
N-ForMyl Valacyclovir N-ForMyl Valacyclovir 847670-62-6 C14H20N6O5
2-Fluorobiphenyl-4-carboxylic Acid 2-Fluorobiphenyl-4-carboxylic Acid 137045-30-8 C13H9FO2
Theophyllidine Hydrochloride Theophyllidine Hydrochloride 116131-08-9 C6H10ClN4O
1,4'-Dimethyl-2'-propyl-2,5'-bi-1H-benzimidazole 1,4'-Dimethyl-2'-propyl-2,5'-bi-1H-benzimidazole 887583-89-3 C19H20N4
Tetracyclics compound impurities Tetracyclics compound impurities
Urapidil Impurity Urapidil Impurity 770-42-3 C8H9BrFN.BrH
N'-(1-Methylazepan-4-yl)benzohydrazine N'-(1-Methylazepan-4-yl)benzohydrazine 117078-69-0 C14H22ClN3O
3-(3-Chloropropyl)-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one 3-(3-Chloropropyl)-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one 85175-65-1 C15H20ClNO3
N-DesMethyl TelMisartan N-DesMethyl TelMisartan 144701-81-5 C32H28N4O2
N-De[2-(Methylsulfonyl)ethyl] Lapatinib N-De[2-(Methylsulfonyl)ethyl] Lapatinib 697299-82-4 C26H20ClFN4O2
N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole Sulfide N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole Sulfide 957470-58-5 C24H24F2N4O5S
Sunitinib N-Oxide Sunitinib N-Oxide 356068-99-0 C22H27FN4O3
Abiraterone Sulfate Abiraterone Sulfate
AtracuriuM IMpurity G (R-Laudanosine) AtracuriuM IMpurity G (R-Laudanosine)
BendaMustine IMpurity D BendaMustine N-Alkylated IMpurity BendaMustine IMpurity D BendaMustine N-Alkylated IMpurity
Cefradine IMpurity E Cefradine IMpurity E
Cetirizine IMpurity-7 Cetirizine IMpurity-7 C21H25ClN2O3
Dasatinib IMpurity 6 Dasatinib IMpurity 6
Desacetyl CefathiaMidine Desacetyl CefathiaMidine 958001-61-1 C17H26N4O5S2
Fluconazole IMpurity D Fluconazole IMpurity D C13H12F2N6O
Lercanidipine IMpurity A Lercanidipine IMpurity A 74936-74-6 C19H22N2O6
Loratadine 2-Chloro IMpurity Loratadine 2-Chloro IMpurity 165739-64-0 C22H22Cl2N2O2
Metoprolol IMpurity F Metoprolol IMpurity F C15H25NO3
Miconazole IMpurity I Miconazole IMpurity I 47363-37-1 C18H15Cl3N2O
Milrinone IMpurity 1 Milrinone IMpurity 1
Nicardipine Related CoMpound 2 Nicardipine Related CoMpound 2 64603-72-1 C16H14N2O6
Saxagliptin IMpurity 1 Saxagliptin IMpurity 1 1564266-73-4 C6H10N2O
Sitagliptin DeaMino IMpurity 1 Sitagliptin DeaMino IMpurity 1 1253056-18-6 C16H12F6N4O
Sitagliptin Defuoro IMpurity 5 Sitagliptin Defuoro IMpurity 5 486460-31-5 C16H16F5N5O
TiMolol IMpurity E TiMolol IMpurity E 1026075-53-5 C17H26N4O6S
EthanediaMide  iMpurity J EthanediaMide iMpurity J C2H4N2O2
4,6-dichloro-2-(propylthio)pyriMidine 4,6-dichloro-2-(propylthio)pyriMidine 1401318-10-2 C7H8Cl2N2S
Istradefylline impurity B Istradefylline impurity B
Ticagrelor diastereoMer Ticagrelor diastereoMer 1459719-81-3 C9H9F2N
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