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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
Vortioxetine Impurity 2 Vortioxetine Impurity 2 1293489-69-6 C17H20N2S
Chrysin 6-C-arabinoside 8-C-glucoside Chrysin 6-C-arabinoside 8-C-glucoside 185145-33-9 C26H28O13
Meloside A Meloside A 60767-80-8 C27H30O15
4-Nitrophenyl 5-chlorothiophene-2-carboxylate 4-Nitrophenyl 5-chlorothiophene-2-carboxylate 1450877-56-1 C11H6ClNO4S
Olaparib iMpurity B Olaparib iMpurity B
Posaconazole iMpurity 6 Posaconazole iMpurity 6 2185472-85-7 C30H35N5O3
Everolimus Isomer C Everolimus Isomer C
(S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid (S)-2-(2-(5-chloro-N-(4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)thiophene-2-carboxamido)ethoxy)acetic acid 1151893-81-0 C24H21Cl2N3O7S2
Cilastatin ammonium salt Cilastatin ammonium salt 877674-82-3 C16H29N3O5S
Deferasirox Salicyloyl Ester Deferasirox Salicyloyl Ester 1395346-28-7 C28H19N3O6
N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol N-2-Hydroxy-3-[[2-(Methoxyphenoxy)ethyl]aMine Carvedilol 1198090-73-1 C36H43N3O7
N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide 253168-86-4 C22H24N2O7S
N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide 253168-86-4 C22H24N2O7S
N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide N-[2-[1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide 253168-86-4 C22H24N2O7S
Ticagrelor IMpurity B Ticagrelor IMpurity B
AtracuriuM IMpurity V AtracuriuM IMpurity V 1075726-86-1 C25H34INO6
Avanafil iMpurity 3 Avanafil iMpurity 3
CitalopraM carboxylic acid iMpurity CitalopraM carboxylic acid iMpurity 440121-09-5 C20H22FNO3
3',5'-Dimethoxytricetin 7-O-β-D-glucopypranoside 3',5'-Dimethoxytricetin 7-O-β-D-glucopypranoside 32769-01-0 C23H24O12
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic acid methyl ester 42019-07-8 C18H17ClO4
IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin) IMp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-Methylisoxazol-4-yl]carbonyl]aMino]Methyl]-5,5-diMethyl- thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin)
IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride IMp. C (EP): (4-(DiphenylMethyl)-1,1-bis[(E)-3-phenylprop-2-enyl]piperaziniuM Chloride 95062-18-3 C35H35ClF2N2
IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid IMp. E (EP): 4-AMino-5-(ethylsulphonyl)-2-Methoxybenzoic Acid
3,5-DiMethyl-1-nitroadaMantane 3,5-DiMethyl-1-nitroadaMantane 6588-68-7 C12H19NO2
2-Deschloro Aripiprazole 2-Deschloro Aripiprazole 203395-82-8 C23H28ClN3O2
6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 6-O-Benzyl-4-dehydroxy-4-diMethylphenylsilyl Entecavir 649761-24-0 C27H31N5O2Si
Desisobutyl-n-butyl BortezoMib Desisobutyl-n-butyl BortezoMib 1104011-35-9 C19H25BN4O4
2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 2-aMino-4-Methoxy-5-(3-Morpholinopropoxy)benzaMide 246512-44-7 C15H23N3O4
N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide N-(4,6-dichloro-2-(propylthio)pyriMidin-5-yl)forMaMide 1402150-28-0 C8H9Cl2N3OS
Ebastine IMpurity G Ebastine IMpurity G 1429071-65-7 C32H39NO3
Decitabine iMpurity 6 Decitabine iMpurity 6 178671-74-4 C7H14N4O4
DiazepaM IMpurity E DiazepaM IMpurity E 20927-53-1 C15H11ClN2O
ErtapeneM Side Chain EnantioMer 2 HCl ErtapeneM Side Chain EnantioMer 2 HCl 503607-49-6 C12H15ClN2O3S
Ribavirin IMpurity G Ribavirin IMpurity G
Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone Ethanone, 1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)- 1-(2,5-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone,1-(2,5-difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanone 1157938-97-0 C10H7F2N3O
3-Fluoro-4-phenylphenol 3-Fluoro-4-phenylphenol 477860-13-2 C12H9FO
Heptyl Deoctyl FingoliMod Hydrochloride Heptyl Deoctyl FingoliMod Hydrochloride 162361-44-6 C18H32ClNO2
4-Methoxy-3,5-diMethylpyridine 1-Oxide 4-Methoxy-3,5-diMethylpyridine 1-Oxide 91219-89-5 C8H11NO2
N-Ethyl-3-buteno-o-toluidide N-Ethyl-3-buteno-o-toluidide 13936-71-5 C13H17NO
Pramipexole Impurity 21 Pramipexole Impurity 21 104617-86-9 C10H17N3S
Tigecycline Pentacyclic Analog Tigecycline Pentacyclic Analog 1268494-40-1 C27H32N4O9
Tigecycline (open C-ring D-ring) Quinone Tigecycline (open C-ring D-ring) Quinone 1268494-46-7 C26H32N4O8
5-Chloro AcesulfaMe 5-Chloro AcesulfaMe 72827-08-8 C4H4ClNO4S
Pazopanib iMpurity Pazopanib iMpurity
Acetic acid, 2-[2-[2-[4-[(4- chlorophenyl)phenylMethyl]-1-piperazinyl]ethoxy]ethoxy]- Acetic acid, 2-[2-[2-[4-[(4- chlorophenyl)phenylMethyl]-1-piperazinyl]ethoxy]ethoxy]- 682323-77-9 C23H29ClN2O4
edaravone iMpurity edaravone iMpurity
(2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol (2R,3R,4R,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-6-(hydroxyMethyl)tetrahydro-2H-pyran-3,4,5-triol C24H25FO5S
Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- Androst-16-en-3-ol, 17-(3-pyridinyl)-, acetate (ester),(3β,5α)- 219843-76-2 C26H35NO2
5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(4-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
Ganciclovir EP Impurity H Ganciclovir EP Impurity H 84222-50-4 C9H13N5O4
2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 2-[4-[(1E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine 97151-10-5 C24H25NO
[S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] [S-(R*,R*)]-3,3'-Dithiobis[2-methylpropanoic acid] 65134-74-9 C8H14O4S2
(E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone (E)-1-(4-(2-Methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)ethanone 935272-10-9 C18H20N4OS
2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 2-(thiophen-3-yl)ethyl 4-methylbenzenesulfonate 40412-09-7 C13H14O3S2
1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 1,3-Dimethyl-5,5-diallylhexahydropyrimidine-2,4,6-trione 722-97-4 C12H16N2O3
DU 6858 DU 6858 127199-06-8 C19H18ClF2N3O3
rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine rac 4-[4-(Oxiranylmethoxy)-1,2,5-thiadiazol-3-yl]morpholine 58827-68-2 C9H13N3O3S
N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester N-Formyl-L-leucine (3S,4S,6S)-3-Hexyltetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester 130676-65-2 C29H53NO5
rac a-Hydroxy Ibuprofen rac a-Hydroxy Ibuprofen 60057-62-7 C13H18O3
3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 3a,7a-dihydroxy-5-(1-methyl-1H-indole-3-carbonyl)-hexahydro-1H-benzo[d]imidazol-2(3H)-one 171967-74-1 C17H19N3O4
5-(5-Chlorosulfonyl-2-ethoxyphenyl)-3-propyl-1,6-dihydro_x000b_-7H-pyrazolo[4,3-d]pyrimidin-7-one 5-(5-Chlorosulfonyl-2-ethoxyphenyl)-3-propyl-1,6-dihydro_x000b_-7H-pyrazolo[4,3-d]pyrimidin-7-one 139756-31-3 C16H17ClN4O4S
5,7-difluorochroman-4-one 5,7-difluorochroman-4-one 844648-22-2 C9H6F2O2
2-[(Azidoacetyl)amino]-2-deoxy-D-glucopyranose 1,3,4,6-tetraacetate 2-[(Azidoacetyl)amino]-2-deoxy-D-glucopyranose 1,3,4,6-tetraacetate 98924-81-3 C16H22N4O10
(3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid (3R,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid 769908-13-6 C25H24FNO4
(7a,17b)-7-7-[9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol 17-acetate (7a,17b)-7-7-[9-[(4,4,5,5,5-Pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol 17-acetate 261506-24-5 C34H49F5O4S
1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid 1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid 1163685-30-0 C14H11N3O3
O-Desethyl Candesartan Cilexetil  O-Desethyl Candesartan Cilexetil 869631-11-8 C31H30N6O6
α-Desmethyl Anastrozole α-Desmethyl Anastrozole 1215780-15-6 C16H17N5
Epi Lovastatin Epi Lovastatin 79952-44-6 C24H36O5
Hydroxy Brimonidine Hydroxy Brimonidine 1216379-05-3 C11H12BrN5O
7-Methoxy-3,4-dihydro-1H-quinolin-2-one 7-Methoxy-3,4-dihydro-1H-quinolin-2-one 22246-17-9 C10H11NO2
4-Methoxy-alpha-methyl-N-(phenylmethyl)benzeneethanamine hydrochloride 4-Methoxy-alpha-methyl-N-(phenylmethyl)benzeneethanamine hydrochloride 1049695-95-5 C17H21NO.HCl
Montelukast Methyl Ketone Montelukast Methyl Ketone 937275-23-5 C34H32ClNO3S
Propyl Itraconazole Propyl Itraconazole 74855-91-7 C34H36Cl2N8O4
Olmesartan Methyl Ketone Olmesartan Methyl Ketone 1227626-45-0 C25H28N6O2
3-methyleneisobenzofuran-1(3H)-one 3-methyleneisobenzofuran-1(3H)-one 3453-63-2 C9H6O2
Irbesartan impurity A Irbesartan impurity A C25H28N6O
(N-tert-Butoxycarbonyl-N-[(1'R)-hydroxy-1-phenyl)ethyl])-4-nitrophenylethylaMine (N-tert-Butoxycarbonyl-N-[(1'R)-hydroxy-1-phenyl)ethyl])-4-nitrophenylethylaMine 223673-35-6 C21H26N2O5
Azelastine N-Oxide Azelastine N-Oxide 640279-88-5 C22H24ClN3O2
Desloratadine Hydroxypiperidine N-Oxide Desloratadine Hydroxypiperidine N-Oxide 1193725-75-5 C19H15ClN2O2
16α,17,21-Trihydroxy-pregna-1,4-diene-3,11,20-trione 16α,17,21-Trihydroxy-pregna-1,4-diene-3,11,20-trione 3754-05-0 C21H26O6
4H-Furo[2,3-c]pyranyl Mupirocin SodiuM IMpurity 4H-Furo[2,3-c]pyranyl Mupirocin SodiuM IMpurity 116182-43-5 C26H43NaO9
4-Methyl Erlotinib Hydrochloride 4-Methyl Erlotinib Hydrochloride 1346601-52-2 C23H25N3O4
5-[[(4-Fluorophenyl)Methyl]aMino]-1,3-dihydro-2H-iMidazo[4,5-b]pyridin-2-one 5-[[(4-Fluorophenyl)Methyl]aMino]-1,3-dihydro-2H-iMidazo[4,5-b]pyridin-2-one 951624-49-0 C13H11FN4O
Perindoprilat LactaM B Perindoprilat LactaM B 130061-28-8 C17H26N2O4
PseudoMonic Acid D SodiuM PseudoMonic Acid D SodiuM 85178-60-5 C26H41NaO9
Parent nucleus of cefotiaM hydrochloride Parent nucleus of cefotiaM hydrochloride 372092-19-8 C13H21N7O3S2
Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) Bisacodyl Related Compound E (20 mg) (2-[(4-Acetoxyphenyl)(pyridin-2-yl)methyl]phenyl acetate) 111664-35-8 C22H19NO4
EsoMeprazole related substance H431/41 EsoMeprazole related substance H431/41 1227380-90-6 C16H15N3O4
(3S,4R)-4-(4-Fluorophenyl)piperidine-3-Methanol Hydrochloride (3S,4R)-4-(4-Fluorophenyl)piperidine-3-Methanol Hydrochloride 220548-73-2 C12H17ClFNO
LaMotrigine IMpurity D LaMotrigine IMpurity D 661463-79-2 C9H5Cl2N3O2
(3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol N-Oxide Sulfate (3β)-17-(3-Pyridinyl)androsta-5,16-dien-3-ol N-Oxide Sulfate C24H31NO5S
DeMethylpiperazinyl Desethyl Sildenafil Sulfonyl Chloride DeMethylpiperazinyl Desethyl Sildenafil Sulfonyl Chloride 139756-27-7 C15H15ClN4O4S
Rizatriptan IMpurity B Rizatriptan IMpurity B 1016900-28-9 C13H15ClN5
rac Adrenaline IMpurity D rac Adrenaline IMpurity D 1095714-91-2 C16H19NO3
2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 2-(1-Methylethenyl)-6-(1-Methylethyl)phenol 74926-89-9 C12H16O
Irinotecan IMpurity G Irinotecan IMpurity G 947687-02-7 C35H42N4O6
5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 5-[Bis(2-hydroxyethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid 109882-30-6 C16H23N3O4
5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 5-Chloro-6'-Methyl-3-[4-(Methylsulfonyl)phenyl]-2,3'-bipyridine 1'-Oxide 325855-74-1 C18H15ClN2O3S
Lafutidine IMpuritiy B Lafutidine IMpuritiy B 174583-84-7 C22H29N3O5S
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