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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
Rubrofusarin triglucoside Rubrofusarin triglucoside 245724-07-6 C33H42O20
Gabapentin EP Impurity G Gabapentin EP Impurity G 1500558-49-5 C10H19NO2
2-butyrylbenzoic acid 2-butyrylbenzoic acid 19666-03-6 C11H12O3
Cefminox sodium impurities D Cefminox sodium impurities D
(R)-5-chloro-N-(4-(3-oxomorpholino)phenyl)-N- ((2-oxooxazolidin-5-yl)methyl)thiophene-2-carboxamide (R)-5-chloro-N-(4-(3-oxomorpholino)phenyl)-N- ((2-oxooxazolidin-5-yl)methyl)thiophene-2-carboxamide 1879903-65-7 C19H18ClN3O5S
Cefmetazole impurity Cefmetazole impurity 56796-19-1 C28H27N7O5S3
3-ethylisobenzofuran-1(3H)-one 3-ethylisobenzofuran-1(3H)-one 17475-41-1 C10H10O2
Ivabradine Impurity 21 HCl Ivabradine Impurity 21 HCl 304465-03-0 C26H34N2O5
Moxifloxacin EP Impurity C HCl Moxifloxacin EP Impurity C HCl
Moxifloxacin Impurity 23 Moxifloxacin Impurity 23 855661-74-4 C21H24FN3O4
Solifenacin Related Compound 18 Solifenacin Related Compound 18 1225338-27-1 C23H26N2O2
N-(2-hydroxy-3-(4-((2-isopropoxyethoxy)methyl)phenoxy)propyl) -N-isopropylformamide N-(2-hydroxy-3-(4-((2-isopropoxyethoxy)methyl)phenoxy)propyl) -N-isopropylformamide 1447715-45-8 C19H31NO5
Tofacitinib Related Compound Tofacitinib Related Compound 1206824-85-2 C10H18ClN3O
Fluvastatin EP impurity A -G Fluvastatin EP impurity A -G 93957-58-5 C24H26FNO4
PWKRNMKZGWGSDV-UHFFFAOYSA-N PWKRNMKZGWGSDV-UHFFFAOYSA-N 1422960-88-0 C33H34ClN4+
8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide 8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide 795313-24-5 C14H19BrCl2N2
8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide 8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide 795313-24-5 C14H19BrCl2N2
9-MethoxyMethyl Guanine 9-MethoxyMethyl Guanine 1202645-50-8 C7H9N5O2
Edoxaban Impurity 12 (1R,2R,4S) Edoxaban Impurity 12 (1R,2R,4S) 500572-10-1 C24H30ClN7O4S
paroxetine Mesylate paroxetine Mesylate 217797-14-3 C20H24FNO6S
4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one 4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one 763111-47-3 C20H19FN4O2
ClindaMycin 3-PalMitate ClindaMycin 3-PalMitate 68225-59-2 C34H63ClN2O6S
EltroMbopag Methyl Ester EltroMbopag Methyl Ester 1246929-01-0 C26H24N4O4
ErythroMycin A 6,9-IMino Ether ErythroMycin A 6,9-IMino Ether 99290-97-8 C37H66N2O12
α,α'-Bis[(2-Methoxyphenoxy)Methyl]-1,4-piperazinediethanol α,α'-Bis[(2-Methoxyphenoxy)Methyl]-1,4-piperazinediethanol 333749-57-8 C24H34N2O6
Ticagrelor IMpurity E Ticagrelor IMpurity E 1402150-34-8 C26H30F2N6O5S
Benzenebutanoicacid,b-[[(1,1-diMethylethoxy)carbonyl]aMino]-2,4,5-trifluoro-,Methylester,(bR)- Benzenebutanoicacid,b-[[(1,1-diMethylethoxy)carbonyl]aMino]-2,4,5-trifluoro-,Methylester,(bR)- 881995-73-9 C16H20F3NO4
Bosutinib Impurity 1 Bosutinib Impurity 1 1460227-29-5 C18H13Cl2N3O3
tert-butyl 4-cyclohexylpiperazine-1-carboxylate tert-butyl 4-cyclohexylpiperazine-1-carboxylate 1224935-95-8 C15H28N2O2
Afatinib IMpurity D Afatinib IMpurity D
Afatinib IMpurity D Afatinib IMpurity D
Avanafil iMpurity 1 Avanafil iMpurity 1 372117-54-9 C18H22ClN5O3
Bisoprolol EP IMpurity B HeMifuMarate (Bisoprolol n-Propyl Derivative HeMifuMarate) Bisoprolol EP IMpurity B HeMifuMarate (Bisoprolol n-Propyl Derivative HeMifuMarate) 1447715-44-7 C18H31NO4
Dabigatran iMpurity F Dabigatran iMpurity F 1642853-67-5 C19H20N4O4
Decitabine iMpurity 4 Decitabine iMpurity 4 863396-35-4 C6H12O4
Gliclazide iMpurity D Gliclazide iMpurity D 1136426-19-1 C15H20N2O3S
Losartan IMpurity C (Isolosartan) Losartan IMpurity C (Isolosartan) 114799-13-2 C22H23ClN6O
Posaconazole DiastereoisoMer interMediate 2 Posaconazole DiastereoisoMer interMediate 2 166583-12-6 C21H21F2N3O4S
Quetiapine IMpurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fuMarate)) Quetiapine IMpurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fuMarate)) 1011758-03-4 C19H21N3S
TaMsulosin IMpurity B TaMsulosin IMpurity B C20H28N2O5S
Ticagrelor iMpurity N Ticagrelor iMpurity N
Tirofiban IMpurity (4,4'-Dipyridyl-1,5-Pentane) Tirofiban IMpurity (4,4'-Dipyridyl-1,5-Pentane) 25382-33-6 C15H18N2
3-Quinolinecarbonitrile,4-chloro-6-Methoxy-7-[3-(4-Methyl-1-piperazinyl)propoxy]- 3-Quinolinecarbonitrile,4-chloro-6-Methoxy-7-[3-(4-Methyl-1-piperazinyl)propoxy]- 492444-39-0 C19H23ClN4O2
Vardenafil Oxopiperazine (IMpurity) Vardenafil Oxopiperazine (IMpurity) 448184-58-5 C21H26N6O5S
IverMectin B1 Aglycon IverMectin B1 Aglycon 73162-95-5 C34H50O8
9α-BroMobudesonide 9α-BroMobudesonide 313474-59-8 C25H33BrO6
N-(5-Chloro-2-pyridinyl)-2-pyrazinecarboxaMide (Zopiclone IMpurity) N-(5-Chloro-2-pyridinyl)-2-pyrazinecarboxaMide (Zopiclone IMpurity) 349125-10-6 C10H7ClN4O
2-Methyl SiMvastatin (Mixture Of DiasteroisoMers) 2-Methyl SiMvastatin (Mixture Of DiasteroisoMers) 774611-54-0 C26H40O5
(4-Chloro-3,5-diMethylpyridin-2-yl)Methanol Hydrochloride (4-Chloro-3,5-diMethylpyridin-2-yl)Methanol Hydrochloride 143016-70-0 C8H11Cl2NO
AMoxicillin DiMer (penicilloic acid forM) AMoxicillin DiMer (penicilloic acid forM) 210289-72-8 C32H40N6O11S2
AMoxicillin DiMer (penicilloic acid forM) AMoxicillin DiMer (penicilloic acid forM) 210289-72-8 C32H40N6O11S2
Desacetyl-7-ACA Lactone Desacetyl-7-ACA Lactone 184696-69-3 C8H8N2O3S
5,6-DiMethoxy-2-[(4-piperidyl)Methyl]indane Hydrochloride (Donepezil IMpurity) 5,6-DiMethoxy-2-[(4-piperidyl)Methyl]indane Hydrochloride (Donepezil IMpurity) 1034439-43-4 C17H26ClNO2
CarfilzoMib IMpurity CarfilzoMib IMpurity 1541171-65-6 C41H61N5O10S
S,S-Efinaconazole S,S-Efinaconazole 164650-45-7 C18H22F2N4O
BendaMustine IMpurity BendaMustine IMpurity
Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester 85014-68-2 C11H13ClN2O3
D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester 1496552-28-3 C22H29FN3O9P
D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)- 842133-16-8 C24H26O5S
Phthalic acid, 3,3'-azoxydi- (8CI) Phthalic acid, 3,3'-azoxydi- (8CI) 22895-28-9 C16H10N2O9
(alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile (alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile 1150310-15-8 C15H15N3O5
(2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide (2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide 857629-79-9 C16H19N3O5
(R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate (R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate 149709-59-1 C25H31NO4
1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97% 1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97% 20529-23-1 C14H23N3O
(R)-3-((S)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (R)-3-((S)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 404874-94-8 C20H20FNO4
(S)-3-((S)-5-hydroxy-5-phenylpentanoyl)-4-phenyloxazolidin-2-one (S)-3-((S)-5-hydroxy-5-phenylpentanoyl)-4-phenyloxazolidin-2-one C20H21NO4
Apixaban Impurity 20 Apixaban Impurity 20 1421823-20-2 C27H29ClN4O5
Posaconazole iMpurity 4 Posaconazole iMpurity 4 2125944-53-6 C30H35N5O3
Everolimus Ring-Opening Impurity Everolimus Ring-Opening Impurity 1708118-13-1 C53H83NO14
Topiroxostat Impurity 6 Topiroxostat Impurity 6 2044704-63-2 C7H8N4O2
Dienogest Impurity I Dienogest Impurity I 65928-65-6 C20H27NO2
Febuxostat Impurity 8 Febuxostat Impurity 8 144060-62-8 C16H17NO4S
Lornoxicam Impurity 9 Lornoxicam Impurity 9 70374-36-6 C6H6ClNO4S2
Ticagrelor Related Compound 3 Ticagrelor Related Compound 3 88756-83-6 C8H15NO3
135270-10-9 135270-10-9 135270-10-9 C12H11F2N3O
Tadalafil EP Impurity Tadalafil EP Impurity 479545-76-1 C21H16N2O5
Vonoprazan Impurity C Vonoprazan Impurity C
(5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one (5RS)-5-Ethyl-2,6-diimino-5-phenyl-1,2,5,6-tetrahydropyrimidin-4(3H)-one 69125-70-8 C12H14N4O
4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 4-(benzyloxy)-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid 942195-83-7 C16H14N2O3
Tofacitinib Impurity G Tofacitinib Impurity G
Ceftaroline Fosamil Impurity 6 Ceftaroline Fosamil Impurity 6 953037-71-3 C22H20N8O5S4
Zolmitriptan Related Compound F Zolmitriptan Related Compound F 1350928-05-0 C38H53N7O4
4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol 4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butan-1-ol 913614-15-0 C16H22N2OS
3-((methoxycarbonyl)methyl)-5-methylhexanoic acid 3-((methoxycarbonyl)methyl)-5-methylhexanoic acid 181289-11-2 C10H18O4
Cyanocobalamin Impurity F Cyanocobalamin Impurity F 23208-66-4 C63H85CoN13O15P
Acarbose Impurity D Acarbose Impurity D
Acarbose Impurity D Acarbose Impurity D
Acarbose Impurity C Acarbose Impurity C
Acarbose Impurity C Acarbose Impurity C
Nintedanib Impurity G (Intedanib Impurity G) Nintedanib Impurity G (Intedanib Impurity G)
Canagliflozin alpha-Isomer Impurity Canagliflozin alpha-Isomer Impurity
Dapagliflozin Impurity 4 Dapagliflozin Impurity 4
Isavuconazole Impurity 9 Isavuconazole Impurity 9
Apremilast Impurity E Apremilast Impurity E
Bisoprolol EP Impurity N Bisoprolol EP Impurity N 1346601-75-9 C17H29NO4
Rosuvastatin EP Impurity J Rosuvastatin EP Impurity J
Bosutinib Impurity Bosutinib Impurity 380843-12-9 C19H15Cl2N3O3
4-(4-Chloro-pyrimidin-2-ylamino)-benzamide 4-(4-Chloro-pyrimidin-2-ylamino)-benzamide 1629023-90-0 C18H12N6
Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate Methyl 4-(4-fluorophenyl)-6-isopropyl-2-oxo-1,2,3,4-tetrahydropyrimidine-5-carboxylate 488798-36-3 C15H17FN2O3
Nateglinide Methyl Ester Nateglinide Methyl Ester 105746-47-2 C20H29NO3
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