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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
Adefovir  iMpurity Adefovir iMpurity 1875153-79-9 C15H24N5O6P
Anastrozole iMpurity Anastrozole iMpurity
Anastrozole iMpurity Anastrozole iMpurity
LevosiMendan iMpurity LevosiMendan iMpurity 139052-02-1
DESVENLAFAXINE SUCCINATE DESVENLAFAXINE SUCCINATE 448904-47-0 C20H31NO6
IMp. H (EP): (2R)-2-[(2,2-DiMethylpropanoyl)aMino]-2-(4-hydroxyphenyl)acetic Acid IMp. H (EP): (2R)-2-[(2,2-DiMethylpropanoyl)aMino]-2-(4-hydroxyphenyl)acetic Acid C16H19N3O5S
Desloratadine IMpurity B Desloratadine IMpurity B 117796-50-6 C19H19BrN2
Itraconazole IMpurity B Itraconazole IMpurity B
Benzene, 1-(3-chloropropyl)-3-(trifluoroMethyl)- Benzene, 1-(3-chloropropyl)-3-(trifluoroMethyl)- 82258-76-2 C10H10ClF3
N-Methyl-N-((3S,4S)-4-Methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyriMidin-4-aMine N-Methyl-N-((3S,4S)-4-Methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyriMidin-4-aMine 1260614-73-0 C13H19N5
2-(5-oxo-5H-chroMeno[2,3-b]pyridin-7-yl)propanoic acid 2-(5-oxo-5H-chroMeno[2,3-b]pyridin-7-yl)propanoic acid 52549-19-6 C15H11NO4
1H-BenziMidazole, 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]Methyl]sulfinyl]-1-(2,2,2-trifluoroethyl)- 1H-BenziMidazole, 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]Methyl]sulfinyl]-1-(2,2,2-trifluoroethyl)- 1187926-84-6 C18H15F6N3O2S
4,5-dihydro-a-(hydroxyMethyl)-a,3-diMethyl-5-oxo-1-phenyl-1H-Pyrazole-4-Methanesulfonic acid 4,5-dihydro-a-(hydroxyMethyl)-a,3-diMethyl-5-oxo-1-phenyl-1H-Pyrazole-4-Methanesulfonic acid 1242471-40-4 C13H16N2O5S
Epalrestat iMpurity Epalrestat iMpurity 109801-00-5 C13H18O
5-Oxo Pitavastatin 5-Oxo Pitavastatin 222306-15-2 C25H22FNO4
(3R)-2,3-Dihydro-3-(2-propyn-1-ylaMino)-1H-inden-1-one (3R)-2,3-Dihydro-3-(2-propyn-1-ylaMino)-1H-inden-1-one 1312077-05-6 C12H11NO
1-[[2'-(AMinoiMinoMethyl)[1,1'-biphenyl]-4-yl]Methyl]-2-ethoxy-1H-benziMidazole-7-carboxylic Acid 1-[[2'-(AMinoiMinoMethyl)[1,1'-biphenyl]-4-yl]Methyl]-2-ethoxy-1H-benziMidazole-7-carboxylic Acid 1442400-65-8 C24H22N4O3
2-Hydroxy Cephalexin 2-Hydroxy Cephalexin 215172-75-1 C16H17N3O5S
(3S,5S)-Fluvastatin Sodium Salt (3S,5S)-Fluvastatin Sodium Salt 194935-01-8 C24H27FNNaO4
Betaxolol EP Impurity A Betaxolol EP Impurity A 67193-95-7 C14H23NO2
3,5-Bis(benzyloxy)benzoic acid benzyl ester 3,5-Bis(benzyloxy)benzoic acid benzyl ester 50513-72-9 C28H24O4
[(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]methanesulfonic acid [(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]methanesulfonic acid 117-38-4 C12H15N3O4S
p-Methylcinnamic acid ethyl ester p-Methylcinnamic acid ethyl ester 24393-49-5 C12H14O2
3-[(2-Hydroxyethyl)amino]propiononitrile 3-[(2-Hydroxyethyl)amino]propiononitrile 33759-44-3 C5H10N2O
2-Amino-5-bromobenzaldehyde 2-Amino-5-bromobenzaldehyde 29124-57-0 C7H6BrNO
(R)-(+)-3-(N-METHYLAMINO)-1-(2-THIENYL)-1-PROPANOL (R)-(+)-3-(N-METHYLAMINO)-1-(2-THIENYL)-1-PROPANOL 116539-57-2 C8H13NOS
3-OXO-3,4-DIHYDROPYRAZINE-2-CARBONITRILE 3-OXO-3,4-DIHYDROPYRAZINE-2-CARBONITRILE 81411-78-1 C5H3N3O
RP 48497 (Eszopiclone Impurity C) RP 48497 (Eszopiclone Impurity C) 148891-53-6 C11H7ClN4O
3-(1-methyl-1H-indole-3-carbonyl)hexanedioic acid 3-(1-methyl-1H-indole-3-carbonyl)hexanedioic acid 1352491-75-8 C16H17NO5
Decladinose Roxithromycin (Roxithromycin Impurity B) Decladinose Roxithromycin (Roxithromycin Impurity B) 214902-82-6 C33H62N2O12
Unii-o0p4I5851i Unii-o0p4I5851i 139563-29-4 C28H37ClN4O2S
2-AMino-5-(trifluoroMethoxy)phenyl Thiocyanate 2-AMino-5-(trifluoroMethoxy)phenyl Thiocyanate 1391054-04-8 C8H5F3N2OS
Bisacodyl Related Compound B (20 mg) (2,4'-(Pyridin-2-ylmethylene)diphenol) Bisacodyl Related Compound B (20 mg) (2,4'-(Pyridin-2-ylmethylene)diphenol) 16985-05-0 C18H15NO2
Doxepin Related Compound C (25 mg) ((E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride) Doxepin Related Compound C (25 mg) ((E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride) 4504-96-5 C18H20ClNO
(Z)-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylic acid (Z)-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylic acid 1174733-90-4 C10H14N4O6
rac Cinacalcet HCl rac Cinacalcet HCl 1025064-33-8 C22H22F3N
Acyclovir IMpurity I Acyclovir IMpurity I
AtracuriuM Besylate IMpurity D Iodide (Mixture of DiastereoMers) AtracuriuM Besylate IMpurity D Iodide (Mixture of DiastereoMers)
AzithroMycin IMpurity D AzithroMycin IMpurity D
AztreonaM IMpurity E AztreonaM IMpurity E
Dasatinib IMpurity 1 Dasatinib IMpurity 1
Deferasirox IMpurity 1 Deferasirox IMpurity 1
Doxycycline Hyclate IMpurity F Doxycycline Hyclate IMpurity F 122861-53-4 C23H25NO8
IpratropiuM BroMide IMpurity E IpratropiuM BroMide IMpurity E 183626-76-8 C19H27NO3
Minoxidil IMpurity D Minoxidil IMpurity D 75105-16-7 C11H12N4O4S
Ribavirin IMp. D (EP) Ribavirin IMp. D (EP)
SalMeterol IMpurity C SalMeterol IMpurity C C25H37NO4
SulbactaM IMpurity F SulbactaM IMpurity F
5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 881677-11-8 C16H11FN2O3S
N-(4-(2-Methyl-1,4,5,6-tetrahydrobenzo[b]iMidazo[4,5-d]azepine-1-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide N-(4-(2-Methyl-1,4,5,6-tetrahydrobenzo[b]iMidazo[4,5-d]azepine-1-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide C32H26N4O2
1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 2098457-92-0 C26H27N5O4
1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 2098457-92-0 C26H27N5O4
3-(9H-Carbazol-4-yloxy)-1,2-propanediol 3-(9H-Carbazol-4-yloxy)-1,2-propanediol 123119-89-1 C15H15NO3
4-(2-Methylpropoxy)-1,3-benzenedicarbothioaMide 4-(2-Methylpropoxy)-1,3-benzenedicarbothioaMide 1330632-46-6 C12H16N2OS2
Capecitabine Related Compound A Capecitabine Related Compound A
1-Pyrrolidineaceticacid,2-(aminocarbonyl)-,(2S)-(9CI) 1-Pyrrolidineaceticacid,2-(aminocarbonyl)-,(2S)-(9CI) 277751-02-7 C7H12N2O3
2-Pyrrolidinecarbonitrile,1-acetyl-,(2S)-(9CI) 2-Pyrrolidinecarbonitrile,1-acetyl-,(2S)-(9CI) 700376-84-7 C7H10N2O
1-Azetidinesulfonamide(9CI) 1-Azetidinesulfonamide(9CI) 654073-32-2 C3H8N2O2S
LIMONIN17-BETA-D-GLUCOPYRANOSIDE LIMONIN17-BETA-D-GLUCOPYRANOSIDE 123564-61-4 C32H42O14
(S)-4-(4-Nitrobenzyl)-2-oxazolidinone (S)-4-(4-Nitrobenzyl)-2-oxazolidinone 139264-55-4 C10H10N2O4
6-(Benzyloxy)-9-((1S,3S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine 6-(Benzyloxy)-9-((1S,3S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine 142217-80-9 C53H49N5O4
2-(4-Hydroxymethylphenyl)phenylsulfonamide 2-(4-Hydroxymethylphenyl)phenylsulfonamide 158144-55-9 C15H14O3
4-[2-(CYCLOPROPYLMETHOXY)ETHYL]PHENOL 4-[2-(CYCLOPROPYLMETHOXY)ETHYL]PHENOL 63659-16-5 C12H16O2
PLANTAGININ PLANTAGININ 26046-94-6 C21H20O11
2-(2-Chloroethyl)thiophene 2-(2-Chloroethyl)thiophene 19995-38-1 C6H7ClS
2'',3'',5''-Triacetyl -azacytidine 2'',3'',5''-Triacetyl -azacytidine 10302-78-0 C14H18N4O8
N-Methyl Pantoprazole, mixture of 1 and 3 isomers N-Methyl Pantoprazole, mixture of 1 and 3 isomers 624742-53-6 C17H17F2N3O4S
N-DESMETHYLGALANTHAMINE N-DESMETHYLGALANTHAMINE 41303-74-6 C16H19NO3
2-[6-(2-hydroxy-2-phenyl-ethyl)-1-methyl-2-piperidyl]-1-phenyl-ethanol 2-[6-(2-hydroxy-2-phenyl-ethyl)-1-methyl-2-piperidyl]-1-phenyl-ethanol 552-72-7 C22H29NO2
4-Amino-1-3,5-di-O-benzoyl-2-deoxy-2,2-difluoro-a-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone 4-Amino-1-3,5-di-O-benzoyl-2-deoxy-2,2-difluoro-a-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone 134790-40-2 C23H19F2N3O6
Granisetron Impurity C Granisetron Impurity C 160177-67-3 C17H22N4O
Amoxicillin Diketopiperazine (Mixture of Diastereomers) Amoxicillin Diketopiperazine (Mixture of Diastereomers) 94659-47-9 C16H19N3O5S
Amoxicillin Diketopiperazine (Mixture of Diastereomers) Amoxicillin Diketopiperazine (Mixture of Diastereomers) 94659-47-9 C16H19N3O5S
Atorvastatin Oxirane Impurity Atorvastatin Oxirane Impurity 1246818-88-1 C26H24FNO3
Dehydro Lovastatin Dehydro Lovastatin 109273-98-5 C24H34O4
(3S)-3-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-4,5-dihydro-2-benzoxepin-1(3H)-one (3S)-3-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-4,5-dihydro-2-benzoxepin-1(3H)-one 1100617-38-6 C27H20ClNO2
O-Desethyl N-Trityl Candesartan Cilexetil O-Desethyl N-Trityl Candesartan Cilexetil 934495-65-5 C50H44N6O6
rac Des(isopropoxyethyl)-2-isopropoxyethoxymethyl Bisoprolol rac Des(isopropoxyethyl)-2-isopropoxyethoxymethyl Bisoprolol 1215342-36-1 C19H33NO5
N-(Ethylamino) Fluvoxamine
N-(Ethylamino) Fluvoxamine 1217262-11-7 C17H26F3N3O2
Iso Ribavirin (Ribavirin Impurity G) Iso Ribavirin (Ribavirin Impurity G) 39030-43-8 C8H12N4O5
(R)-(+)-Tolvaptan (R)-(+)-Tolvaptan 331947-66-1 C26H25ClN2O3
(Z)-Cefdinir (Z)-Cefdinir 178601-88-2 C14H13N5O5S2
Flucloxacillin impurity E Flucloxacillin impurity E
4-(4-Piperidyl)-1-butanol 4-(4-Piperidyl)-1-butanol 57614-92-3 C9H19NO
Pitavastatin Methyl Ester Pitavastatin Methyl Ester 849811-78-5 C26H26FNO4
1-Cyclopropyl-1,4-dihydro-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid 1-Cyclopropyl-1,4-dihydro-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid 1029364-73-5 C22H27N3O5
3S,5R isoMer, or (3S,5R)-7-[3-(phenylcarbaMoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calciuM salt 3S,5R isoMer, or (3S,5R)-7-[3-(phenylcarbaMoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid calciuM salt 887196-25-0 C33H34CaFN2O5+
3'-O-(5'-Deoxy-α-D-ribofuranosyl) Capecitabine 3'-O-(5'-Deoxy-α-D-ribofuranosyl) Capecitabine 1262133-64-1 C20H30FN3O9
5-Chlorodescyano CitalopraM Oxalate 5-Chlorodescyano CitalopraM Oxalate 64169-46-6 C21H23ClFNO5
Acyclovir N-Methyl-L-valinate Hydrochloride Acyclovir N-Methyl-L-valinate Hydrochloride 1346617-39-7 C14H23ClN6O4
rac N,N-DidesMethyl-N-(4-hydroxyphenethyl)-O-desMethyl Venlafaxine rac N,N-DidesMethyl-N-(4-hydroxyphenethyl)-O-desMethyl Venlafaxine 1346601-21-5 C22H29NO3
rac-11-Deoxy-8(12)-dehydro Misoprostol rac-11-Deoxy-8(12)-dehydro Misoprostol 1331639-92-9 C22H36O4
5-Nitro-1H-iMidazole-1-ethanol 5-Nitro-1H-iMidazole-1-ethanol 5006-68-8 C5H7N3O3
Hydroxy Adapalene Hydroxy Adapalene 1346599-76-5 C28H28O4
Iohexol related Compound I Iohexol related Compound I
1-(2,3-dichlorophenyl)-4-(4-hydroxybutyl)piperazine 1-(2,3-dichlorophenyl)-4-(4-hydroxybutyl)piperazine 870765-38-1 C14H20Cl2N2O
2,2'-Methylene Bis[Ranitidine] 2,2'-Methylene Bis[Ranitidine] 207592-21-0 C27H44N8O6S2
ChloroMethyl Propyl Carbonate ChloroMethyl Propyl Carbonate 35273-90-6 C5H9ClO3
Imiquimod Related Compound B (25 mg) (1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide) Imiquimod Related Compound B (25 mg) (1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide) 99010-63-6 C14H15N3O
Ioversol Related Compound B (50 mg) (N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbamoyl)methoxy]-2,4,6-triiodoisophthalamide) Ioversol Related Compound B (50 mg) (N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbamoyl)methoxy]-2,4,6-triiodoisophthalamide) 104517-96-6 C18H24I3N3O9
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