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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
Atorvastatin LactaM Phenanthrene CalciuM Salt Atorvastatin LactaM Phenanthrene CalciuM Salt 1046378-58-8 C33H35CaFN2O6
Avanafil IMpurity 7 Avanafil IMpurity 7
Desfluoro flurbiprofen axetil Desfluoro flurbiprofen axetil 1685278-08-3 C19H20O4
Desloratadine IMpurity 6 Desloratadine IMpurity 6 38092-90-9 C20H21ClN2
ErtapeneM Ring Open IMpurity ErtapeneM Ring Open IMpurity
LincoMycin iMpurity C LincoMycin iMpurity C
Norfloxacin iMpurity E Norfloxacin iMpurity E
Posaconazole iMpurity 2 Posaconazole iMpurity 2
Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] 2206135-50-2 C25H18N2S2
Rabeprazole iMpurity (Chloro interMediate) Rabeprazole iMpurity (Chloro interMediate)
TaMsulosin IMpurity F TaMsulosin IMpurity F C20H28N2O5S
TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) 113323-39-0 C28H45NO4S
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 848814-27-7 C21H27N3O3S
(3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester (3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester 204254-90-0 C15H24O7S
TorseMide Carboxylic Acid TorseMide Carboxylic Acid 113844-99-8 C16H18N4O5S
(3S,5R)-Fluvastatin SodiuM Salt (3S,5R)-Fluvastatin SodiuM Salt 94061-81-1 C24H25FNNaO4
(6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone (6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone 1402819-05-9 C17H11Br3O3
ApreMilast IMpurity ApreMilast IMpurity 2438558-63-3 C21H22N2O7S
4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 90038-00-9 C12H17ClN2O
Metoprolol Acid Ethyl Ester Metoprolol Acid Ethyl Ester 29112-40-1 C16H25NO4
6-Hydroxy Desloratadine 6-Hydroxy Desloratadine 119410-05-8 C19H19ClN2O
10-Acetyloxy Oxcarbazepine 10-Acetyloxy Oxcarbazepine 113952-21-9 C17H14N2O4
N-(3-(6-acrylamido-5-(2-(N-methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide N-(3-(6-acrylamido-5-(2-(N-methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide
4-[[(1S)-1-carboxy-2-(4-hydroxyphenyl)ethyl]amino]-4-xobutanoic acid 4-[[(1S)-1-carboxy-2-(4-hydroxyphenyl)ethyl]amino]-4-xobutanoic acid
Hydrocortisone Impurity 58 Disodium Salt (Mixture of Diastereomers) Hydrocortisone Impurity 58 Disodium Salt (Mixture of Diastereomers)
Levomepromazine EP Impurity D HCl Levomepromazine EP Impurity D HCl
Semaglutide Impurity 9 (L-2-Oxohistidine) Semaglutide Impurity 9 (L-2-Oxohistidine)
Radicicol Impurity 1 Radicicol Impurity 1 459126-69-3
3-((1-((4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy)benzonitrile 3-((1-((4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy)benzonitrile
(2R,3R,4S,5R,6R)-6-((1S,2S)-2-chloro-1-((2S,4R)-1-methyl-4- propylpyrrolidine-2-carboxamido)propyl)-4,5-dihydroxy-2-((S)- methylsulfinyl)tetrahydro-2H-pyran-3-yl dihydrogen phosphate (2R,3R,4S,5R,6R)-6-((1S,2S)-2-chloro-1-((2S,4R)-1-methyl-4- propylpyrrolidine-2-carboxamido)propyl)-4,5-dihydroxy-2-((S)- methylsulfinyl)tetrahydro-2H-pyran-3-yl dihydrogen phosphate
9-[[2-(α-L-Alanyloxy)ethoxy]methyl]guanine Hydrochloride 9-[[2-(α-L-Alanyloxy)ethoxy]methyl]guanine Hydrochloride 84499-63-8 C11H17ClN6O4
Irinotecan Impurity 26 Irinotecan Impurity 26 86639-51-2 C22H20N2O5
Bis(aminoethoxy) Amlodipine Bis(aminoethoxy) Amlodipine 721958-74-3 C22H30ClN3O6
7,8,9,10-Dehydro Doxorubicinone 7,8,9,10-Dehydro Doxorubicinone 1159977-23-7 C21H14O8
4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetamide
(Oxymetazoline hydrochloride impurity) 4-tert-Butyl-2,6-dimethyl-3-hydroxyphenylacetamide (Oxymetazoline hydrochloride impurity) 55699-13-3 C14H21NO2
(S)-N-Demethyl Dapoxetine (S)-N-Demethyl Dapoxetine 147199-39-1 C20H21NO
Famotidine Related Compound A Hydrochloride Famotidine Related Compound A Hydrochloride 76833-47-1 C8H15ClN6S2
Des(trifluoroethyl) Lansoprazole Sulfide Des(trifluoroethyl) Lansoprazole Sulfide 131926-97-1 C14H13N3OS
Desulfo Aztreonam Desulfo Aztreonam 102579-59-9 C13H17N5O5S
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 130793-30-5 C22H44O4
Helium-Argon mixture Helium-Argon mixture
Mosapride Citric Amide Mosapride Citric Amide 1215825-20-9 C27H31ClFN3O9
(1,2,4-Triazol-4-yl) Itraconazole (1,2,4-Triazol-4-yl) Itraconazole 854372-77-3 C35H38Cl2N8O4
6,7,8,9-Tetrahydro Carvedilol 6,7,8,9-Tetrahydro Carvedilol 1246820-73-4 C24H30N2O4
Cefdinir Lactone Cefdinir Lactone 946573-41-7 C14H13N5O5S2
Ozagrel methylester Ozagrel methylester 866157-50-8 C13H12N2O2
2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 163685-38-9 C15H25NO3
2-aMino-3-Methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid 2-aMino-3-Methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid 118175-11-4 C7H12N4O4S
HERBA PLANTAGINIS HERBA PLANTAGINIS
fenofibrate  iMpurity fenofibrate iMpurity
6,11-Di-O-Methyl ErythroMycin 6,11-Di-O-Methyl ErythroMycin 81103-14-2 C39H71NO13
ent-OseltaMivir Phosphate ent-OseltaMivir Phosphate 1035895-89-6 C16H29N2O8P
3,5,3',5'-Tetraiodo Thyrolactic Acid 3,5,3',5'-Tetraiodo Thyrolactic Acid 7069-47-8 C15H10I4O5
5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 381233-79-0 C10H7BrN2O
1,4,8,11-Tetraazacy clotetradecance, 1,4,8-tris[(4 Methylphenyl)sufonyl]- 1,4,8,11-Tetraazacy clotetradecance, 1,4,8-tris[(4 Methylphenyl)sufonyl]- 104395-69-9 C31H42N4O6S3
(1S)-N-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-1,2,3,4-tetrahydro-1-naphthalenecarboxaMide (1S)-N-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-1,2,3,4-tetrahydro-1-naphthalenecarboxaMide 177793-79-2 C18H24N2O
(E)-Ceftriaxone (E)-Ceftriaxone 92143-31-2 C18H18N8O7S3
(Z)-Cinnarizine (Z)-Cinnarizine 750512-44-8 C26H28N2
5-BroModescyano CitalopraM 5-BroModescyano CitalopraM 64169-39-7 C19H21BrFNO
Aripiprazole N,N-Dioxide Aripiprazole N,N-Dioxide 573691-13-1 C23H27Cl2N3O4
Deschloro Cetirizine Dihydrochloride Deschloro Cetirizine Dihydrochloride 83881-54-3 C21H26N2O3
DesvancosaMinyl VancoMycin DesvancosaMinyl VancoMycin 101485-50-1 C59H62Cl2N8O22
rac N-Desbutyroyl Acebutolol rac N-Desbutyroyl Acebutolol 57898-80-3 C14H22N2O3
rac-Clopidogrel-MP Endo Derivative rac-Clopidogrel-MP Endo Derivative 1346598-12-6 C25H26ClNO6S
1,1'-N-[Methylenebis(sulphanediylethylene)]bis(N'-Methyl-2-nitroethene-1,1-diaMine 1,1'-N-[Methylenebis(sulphanediylethylene)]bis(N'-Methyl-2-nitroethene-1,1-diaMine 1331637-48-9 C11H22N6O4S2
ent-LaMivudine ent-LaMivudine 134680-32-3 C8H11N3O3S
Formoterol O-β-D-Glucuronide Formoterol O-β-D-Glucuronide 615551-59-2 C25H32N2O10
Mono-POC Tenofovir 6-Isopropyl CarbaMate Mono-POC Tenofovir 6-Isopropyl CarbaMate 1244022-56-7 C18H28N5O9P
N-Methyl Iso Desloratadine N-Methyl Iso Desloratadine 183198-48-3 C20H21ClN2
Tartaric Acid Isopropyl Ester Tartaric Acid Isopropyl Ester 116601-09-3 C7H12O6
Vardenafil Acetyl Analogue Vardenafil Acetyl Analogue 1261351-28-3 C25H34N6O3
Ribavirin Related Compound A (15 mg) (1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid) Ribavirin Related Compound A (15 mg) (1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid) 39925-19-4 C8H11N3O6
N1-Methylbenzene-1,2,4-triaMine N1-Methylbenzene-1,2,4-triaMine 60651-29-8 C7H11N3
RocuroniuMbroMide iMpurity H RocuroniuMbroMide iMpurity H
1-[(2'-carbaMoylbiphenyl-4-yl) Methyl]-2-ethoxybenziMidazole-7-carboxylic acid 1-[(2'-carbaMoylbiphenyl-4-yl) Methyl]-2-ethoxybenziMidazole-7-carboxylic acid 1696392-11-6 C24H21N3O4
5-chloro-1-(3-diMethylaMinopropyl)-1-(4-fluorophenyl)-phthalan 5-chloro-1-(3-diMethylaMinopropyl)-1-(4-fluorophenyl)-phthalan 64169-45-5 C19H21ClFNO
dextroMethorphanone dextroMethorphanone
oxiracetaM related substance ISF3886 oxiracetaM related substance ISF3886 120428-80-0 C8H13N3O4
Carvedilol IMpurity D Carvedilol IMpurity D 1391052-16-6 C39H39N3O6
DL-2-(4-Carboxyphenyl)propionic Acid DL-2-(4-Carboxyphenyl)propionic Acid 67381-50-4 C10H10O4
Betamethasone 17-Propionate 21-Mesylate Betamethasone 17-Propionate 21-Mesylate 15423-80-0 C26H35FO8S
ClarithroMycin EP IMpurity F ClarithroMycin EP IMpurity F 128940-83-0 C39H71NO13
3(R)-Hydroperoxy Simvastatin 3(R)-Hydroperoxy Simvastatin 1092716-42-1 C25H38O7
Albendazole EP IMpurity F Albendazole EP IMpurity F 80983-45-5 C10H11N3O2S
10-Dehydrobaccatin V 10-Dehydrobaccatin V 151636-94-1 C29H34O10
DoxylaMine EP IMpurity A DoxylaMine EP IMpurity A 873407-01-3 C17H22N2O
((1R,3R,E)-5-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-diMethylhept-3-en-2-yl)-7a-Methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-Methylenecyclohexane-1,3-diyl)bis(oxy)bis(tert-butyldiMethylsilane) ((1R,3R,E)-5-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-diMethylhept-3-en-2-yl)-7a-Methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-Methylenecyclohexane-1,3-diyl)bis(oxy)bis(tert-butyldiMethylsilane) 115540-28-8 C40H72O2Si2
Clopidogrel EP IMpurity D Clopidogrel EP IMpurity D 1421283-60-4 C24H21Cl2NO4S
Loratadine IMpurity E Loratadine IMpurity E C22H23ClN2O2
Metoprolol IMpurity E Metoprolol IMpurity E C15H25NO3
IMp. A (EP): 4-Methyl-6-(1-Methyl-1H-benziMidazol-2-yl)-2-propyl-1H-benziMidazole IMp. A (EP): 4-Methyl-6-(1-Methyl-1H-benziMidazol-2-yl)-2-propyl-1H-benziMidazole
(-)-Syringaresinol-4-O-beta-D-glucopyranoside (-)-Syringaresinol-4-O-beta-D-glucopyranoside 137038-13-2 C28H36O13
Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) 910299-74-0 C19H24O4
Etoricoxib Impurity 12 Etoricoxib Impurity 12 646459-41-8 C21H16ClN3O2S
Levofloxacin Tetrafluoro Impurity 2 Levofloxacin Tetrafluoro Impurity 2 103995-33-1 C14H12F4O4
Mupirocin Impurity C Mupirocin Impurity C C26H44O9
Verapamil Impurity H Verapamil Impurity H 67018-83-1 C26H36N2O4
Warfarin Impurity 1 Warfarin Impurity 1 55901-61-6 C13H14O
Vitexin -4''-O-glucoside Vitexin -4''-O-glucoside 178468-00-3 C27H30O15
ETHYL 3,4-EPOXYBUTANOATE ETHYL 3,4-EPOXYBUTANOATE 32223-97-5 C6H10O3
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