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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
SalMeterol iMpurity SalMeterol iMpurity 144391-74-2 C25H37NO4
AzithroMycin iMpurity R AzithroMycin iMpurity R
ceftazidiMe iMpurity E ceftazidiMe iMpurity E
CefuroxiMe Axetil iMpurity C CefuroxiMe Axetil iMpurity C 76598-06-6 C18H15Cl3N4O9S
Rupatadine iMpurity D Rupatadine iMpurity D
2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine 2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine 428854-24-4 C17H15FN8
AR-C 124910XX AR-C 124910XX 220347-05-7 C21H24F2N6O3S
Doxazosin iMpurity Doxazosin iMpurity 1219803-95-8 C23H26ClN5O5
Montelukast iMpurity Montelukast iMpurity
Vildagliptin iMpurity A-F Vildagliptin iMpurity A-F 1846606-32-3 C7H10N2O3
NM-2201 NM-2201 837112-21-7 C24H22FNO2
5a-17-(3-Pyridyl)-16-androstene-3-one 5a-17-(3-Pyridyl)-16-androstene-3-one C24H31NO
AMpicillin EP IMpurity E AMpicillin EP IMpurity E
Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi
Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi Anastrozole IMpurity (2-(3-((1H-1,2,4-triazol-1-yl)Methyl)-5-(1-aMino-2-Methyl-1-oxopropan-2-yl)phenyl)-2-Methylpropanoi
AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2)
 tans, trans IsoMer) AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2) tans, trans IsoMer) 1248429-33-5
Ceftriaxone IMpurit B Ceftriaxone IMpurit B
Flucloxacillin IMpurity F Flucloxacillin IMpurity F
ethyl 2-(3-hydroxyphenyl)-4-methylthiazole-5-Carboxylate ethyl 2-(3-hydroxyphenyl)-4-methylthiazole-5-Carboxylate 209538-87-4 C13H13NO3S
Pyridine, 3-Methoxy-2-Methyl-4-nitro-, 1-oxide Pyridine, 3-Methoxy-2-Methyl-4-nitro-, 1-oxide 15931-25-6 C7H8N2O4
1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 1H,3H,5H-pyrrolo[1,2-a]thiazolo[3,4-d]pyrazine5,8,10(5aH,10aH)-trione,dihydro- 161771-76-2 C9H10N2O3S
(Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate (Z)-Methyl 3-aMino-4-(2,4,5-trifluorophenyl)but-2-enoate 881995-70-6 C11H10F3NO2
6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 6-(benzyloxy)-8-(2-broMoacetyl)-2H-benzo[b][1,4]oxazin-3(4H)-one 926319-53-1 C17H14BrNO4
(2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid (2S)-1-[(2S)-2-[[(1S)-3-Phenyl-1-[(2phenylethoxy) carbonyl]propyl]aMino]propanoyl]pyrrolidine-2-carboxylic acid C26H31N2O5
2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid
(Diketopiperazine) 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine) C29H42N8O18S4
Methoxyvinpocetine Methoxyvinpocetine
Butanoic acid, 4-chloro-3-hydroxy-, (3S)- Butanoic acid, 4-chloro-3-hydroxy-, (3S)- 106941-19-9 C4H7ClO3
2- hydroxyl olopatadine hydrochloride iMpurity 2- hydroxyl olopatadine hydrochloride iMpurity 1331822-32-2 C21H23NO4
Anastrozole iMpurity D Anastrozole iMpurity D
Anastrozole iMpurity D Anastrozole iMpurity D
EMtricitabine iMpurity D EMtricitabine iMpurity D
IMp. D (EP) as SodiuM Salt IMp. D (EP) as SodiuM Salt
RocuroniuMbroMide iMpurity G RocuroniuMbroMide iMpurity G
5,11-bisthio-(R,R)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,8-diketone 5,11-bisthio-(R,R)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,8-diketone 72744-67-3 C8H10N2O2S2
IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate) IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate) 562091-56-9 C20H22N3O4P
Lercanidipine IMpurity B Lercanidipine IMpurity B 1119226-97-9 C35 H37 N3 O6
Milrinone IMpurity 2 Milrinone IMpurity 2 400063-10-7 C12H7N3O2
Moxifloxacin Decarboxy Analog Moxifloxacin Decarboxy Analog 1322062-57-6 C20H24FN3O2
Naratriptan IMpurity E Naratriptan IMpurity E 1346746-73-3 C20H32N4O4S2
PraMipexole DiMer IMpurity II PraMipexole DiMer IMpurity II 2206826-82-4 C20H32N6S2
Rosuvastatin Substituted Hydroxy Pentenoic Acid Rosuvastatin Substituted Hydroxy Pentenoic Acid 910867-11-7 C20H24FN3O5S
EthanediaMide  iMpurity k EthanediaMide iMpurity k 2803419-58-9 C2H4N2O2
(1S,2S,3R,5S)-3-(7-hydroxy-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-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 1445580-43-7 C14H21N5O5S
D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)- D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)- 160709-02-4 C14H15F2N3O2
Bivalirudin iMpurity Bivalirudin iMpurity 72378-50-8 C6H8N2O4
2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid 2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid 55699-12-2 C14H20O3
(S)-Fesoterodine FuMarate (S)-Fesoterodine FuMarate 1431511-18-0 C30H41NO7
(3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity) (3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity) 106939-30-4 C19H22FN3O4
(6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione (6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione 531500-48-8 C22H17N3O5
1-(3,5-Dihydroxyphenyl)-2-[(1,1-diMethylethyl)(phenylMethyl)aMino]ethanone HydrobroMide 1-(3,5-Dihydroxyphenyl)-2-[(1,1-diMethylethyl)(phenylMethyl)aMino]ethanone HydrobroMide 94109-61-2 C19H23NO3
2-Methyl-5-(3-(4-(Methylsulfonyl)phenyl)furan-2-yl)pyridine 2-Methyl-5-(3-(4-(Methylsulfonyl)phenyl)furan-2-yl)pyridine 307531-96-0 C17H15NO3S
3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzenesulfonic Acid 3-(1,4-Dihydro-5-Methyl-4-oxo-7-propyliMidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxybenzenesulfonic Acid 437717-43-6 C17H20N4O5S
3-[5-(1,5-Dioxo-5-(p-fluophenylpentyl]-4R-phenyl-2-oxazolidinone 3-[5-(1,5-Dioxo-5-(p-fluophenylpentyl]-4R-phenyl-2-oxazolidinone 404874-93-7 C20H18FNO4
5-[Bis(2-chloroethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid Methyl Ester 5-[Bis(2-chloroethyl)aMino]-1-Methyl-1H-benziMidazole-2-butanoic Acid Methyl Ester 109882-25-9 C17H23Cl2N3O2
(1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester 171596-44-4 C20H18N2O4
Amlodipine-d4 Amlodipine-d4 1185246-14-3 C20H25ClN2O5
rac Des(isopropylaMino) Acebutolol Diol rac Des(isopropylaMino) Acebutolol Diol 96480-91-0 C15H21NO5
(17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile (17α)-17-Hydroxy-3-oxo-19-norpregna-5(10),9(11)-diene-21-nitrile 106111-42-6 C20H25NO2
(3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine (3S)-N-[[(1S)-1,2,3,4-Tetrahydro-1-naphthalenyl]Methyl]-1-azabicyclo[2.2.2]octan-3-aMine 177793-80-5 C18H26N2
4-(4-Fluorophenyl)-1-Methyl- 4-(4-Fluorophenyl)-1-Methyl- 1012886-75-7 C12H15ClFN
5'(S)-Hydroxy SiMvastatin  DISCONTINUED 5'(S)-Hydroxy SiMvastatin DISCONTINUED 149949-05-3 C25H38O6
5'-Epi-LaMivudine 5'-Epi-LaMivudine 136846-20-3 C8H11N3O3S
N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) N-ForMyl-D-ribofuranosyl-3-guanylurea (α/β-Mixture) 686299-20-7 C8H14N4O6
SiMvastatin 4'-Methyl Ether SiMvastatin 4'-Methyl Ether 864357-88-0 C26H40O5
(2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane (2S,3S,5S)-5-(tert-Butoxycarbonylamino)-2-(N-5-thiazolylmethoxycarbonyl)amino-1,6-diphenyl-3-hydroxyhexane 162849-95-8 C28H35N3O5S
1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 1-[3-(Benzoyloxy)propyl]-2,3-dihydro-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carbonitrile 885340-11-4 C32H34F3N3O4
4-DesMethoxy-4-broMo TriMethopriM 4-DesMethoxy-4-broMo TriMethopriM 16285-82-8 C13H15BrN4O2
Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate Diaquo[(1R,2R)-1,2-cyclohexanediaMine]platinuM DiMer Dinitrate 82398-34-3 C12H24N5O5Pt2+
3-(1-Naphthalenyloxy)propiophenone 3-(1-Naphthalenyloxy)propiophenone 41198-42-9 C19H16O2
2-(1,3,2-Dioxaborinan-2-yl)benzamide 2-(1,3,2-Dioxaborinan-2-yl)benzamide 2377611-18-0 C10H12BNO3
Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) Prednicarbate Related Compound C (20 mg) (prednisolone-21-propionate) 5740-62-5 C24H32O6
(1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate (1S,2S,3R,4R)-Methyl 3-((R)-1-acetaMido-2-ethylbutyl)-4-guanidino-2-hydroxycyclopentanecarboxylate 229614-51-1 C16H30N4O4
Bis(4-fluorobenzyl)aMine, 97% Bis(4-fluorobenzyl)aMine, 97% 134227-41-1 C14H13F2N
(3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester (3S,8R,9S,12S)-3,12-Bis(1,1-diMethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylMethyl)-6-[[4-(2-pyridinyl)phenyl]Methyl]-,2,5,6,10,13-pentaazatetradecanedioic Acid 1,14-DiMethyl Ester 1292296-09-3 C38H52N6O7
L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride L-Leucine 2-[(2-AMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]ethyl Ester Hydrochloride 142963-69-7 C14H23ClN6O4
8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 8-Chloro-6,11-dihydro-11-(1,2,3,6-tetrahydro-4-pyridinyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridine Monohydrochloride 432543-89-0 C19H20Cl2N2
1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 1-[(2'-Cyano[1,1'-biphenyl]-4-yl)MethylaMino]-N-pentanoylcyclopentanecarboxaMide 141745-71-3 C25H29N3O2
PF 2825 PF 2825 153012-65-8 C21H28N2O5S
3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 3,3'-[Dithiobis[(2S,4S)-4,2-pyrrolidinediylcarbonyliMino]]bisbenzoic Acid Dihydrochloride 444057-64-1 C24H27ClN4O6S2
Ertapenem Dimer Form D Impurity Ertapenem Dimer Form D Impurity 1199797-41-5 C44H50N6O14S2
S 00218 S 00218 92700-82-8 C15H22N2O4
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
2-Methyl-2-(4-vinylphenyl)propanoic acid 2-Methyl-2-(4-vinylphenyl)propanoic acid 1256584-72-1 C12H14O2
Loratadine IMpurity D Loratadine IMpurity D C22H23ClN2O2
PeMetrexed EP IMpurity A PeMetrexed EP IMpurity A 869791-42-4 C21H23N5O6
Itraconazole EP IMpurity G Itraconazole EP IMpurity G
(1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride (1R,2S)-2-(3,4-difluorophenyl)cyclopropanaMine hydrochloride 1402222-66-5 C9H10ClF2N
4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 4-[4-[4-(Diphenylmethylene)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethyl-benzeneacetic Acid 1187954-57-9 C32H37NO3
(2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride (2S,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-Piperidinetriol Hydrochloride 1370331-33-1 C8H17NO5
(3S,5R)-Rosuvastatin (3S,5R)-Rosuvastatin 1242184-42-4 C22H28FN3O6S
(S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide (S)-5-(2-AMinopropyl)-2-MethoxybenzenesulfonaMide 119714-13-5 C10H16N2O3S
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Afatinib IMpurity I Afatinib IMpurity I 1637254-93-3 C22H19BrClFN4O3
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Aripiprazole iMpurity 2 Aripiprazole iMpurity 2 1424857-93-1 C14H18Cl2N2
Avanafil IMpurity 6 Avanafil IMpurity 6
Cefoxitin iMpurity F (S-Methoxy cefoxitin) Cefoxitin iMpurity F (S-Methoxy cefoxitin)
Clopidogrel IMpurity 1 Clopidogrel IMpurity 1 C15H14ClNO2S
LincoMycin iMpurity A LincoMycin iMpurity A
Posaconazole iMpurity 1 Posaconazole iMpurity 1
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