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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
4,5,6,7-Tetrahydro-thieno[3,2-c]pyridin-2-ol 2-acetate 4,5,6,7-Tetrahydro-thieno[3,2-c]pyridin-2-ol 2-acetate 1151904-85-6 C9H11NO2S
ethyl (R)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate ethyl (R)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate 110548-06-6 C15H13F2NO4
(2S,4S)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2S,4S)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-52-4 C23H29NO4
Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoate Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-2-methyl-4-(2,5-dioxopyrrolidin-1-yl)butanoate 1038924-97-8 C24H27NO4
Cefazoline Impurity A Cefazoline Impurity A
Rifaximin impurity A Rifaximin impurity A
Benzene, 1-chloro-2-(dimethoxymethyl)- Benzene, 1-chloro-2-(dimethoxymethyl)- 70380-66-4 C9H11ClO2
(R)-1-chloro-3-{[(4-chlorophenyl)methylene]amino}propan-2-ol (R)-1-chloro-3-{[(4-chlorophenyl)methylene]amino}propan-2-ol 1450915-93-1 C10H11Cl2NO
3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one 3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one 877402-45-4 C6H5F3N4O
4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine 4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine 1026443-48-0 C17H23NO2
epipinoresinol-4'-O-β-D-glucoside epipinoresinol-4'-O-β-D-glucoside 24404-49-7 C26H32O11
Celecoxib Impurity Celecoxib Impurity 170570-09-9 C18H16F3N3O2S
4-Methylpiperazine-1-carbonyl chloride 4-Methylpiperazine-1-carbonyl chloride 39539-66-7 C6H11ClN2O
4-[2-fluoro-4-[2-(methylcarbamoyl)pyridin-4-yl]oxyanilino]-N-methylpyridine-2-carboxamide 4-[2-fluoro-4-[2-(methylcarbamoyl)pyridin-4-yl]oxyanilino]-N-methylpyridine-2-carboxamide 1855006-12-0 C20H18FN5O3
2,2'-((piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene))bis(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one) 2,2'-((piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene))bis(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one) 1255919-03-9 C38H46N10O8S2
Bortezomib Impurity P Bortezomib Impurity P
Esmolol impurity A Esmolol impurity A
(5-(4-fluorophenyl)thiophen-2-yl)(5-iodo-2-methylphenyl)methanol (5-(4-fluorophenyl)thiophen-2-yl)(5-iodo-2-methylphenyl)methanol 1818268-45-9 C18H14FIOS
Butanoic acid, 3-oxo-, 1-(phenylmethyl)-3-piperidinyl ester Butanoic acid, 3-oxo-, 1-(phenylmethyl)-3-piperidinyl ester 85387-34-4 C16H21NO3
NMEICKDXQPVPKK-UHFFFAOYSA-N NMEICKDXQPVPKK-UHFFFAOYSA-N 120244-82-8 C16H19ClN2O
Epoxy Exemestane (6-Beta Isomer) Epoxy Exemestane (6-Beta Isomer) 152764-31-3 C20H24O3
AFTMPFJWAIDLME-QWHCGFSZSA-N AFTMPFJWAIDLME-QWHCGFSZSA-N 1808087-53-7 C15H19N3O3S
6-Cyclopropyl-10-fluorobenzo[k]phenanthridine 6-Cyclopropyl-10-fluorobenzo[k]phenanthridine 1187966-95-5 C20H14FN
Labetalone hydrochloride Labetalone hydrochloride 96441-14-4 C19H22N2O3.ClH
6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-
7,9-dimethyl-7,9-dihydro-8H-purin-8-one 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dimethyl-7,9-dihydro-8H-purin-8-one 1361569-23-4 C20H17FN8O
5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 2169153-70-0 C10H15NO4S
Bendamustine Impurity 14 Bendamustine Impurity 14
Canagliflozin Impurity 28 Canagliflozin Impurity 28
Edoxaban Impurity 24 (1S,2S,4R) Edoxaban Impurity 24 (1S,2S,4R) 2024614-21-7 C21H30ClN5O5
Edoxaban Impurity 39 Edoxaban Impurity 39 2081883-55-6 C14H27N3O3
Ezetimibe Impurity 34 Ezetimibe Impurity 34 2280081-69-6 C20H21NO4
Linagliptin Impurity 33 Linagliptin Impurity 33 2443735-53-1 C38H42N10O4
Milrinone Impurity 15 Milrinone Impurity 15 156033-07-7 C12H9N3O2
Milrinone Impurity 6 Milrinone Impurity 6
Pantoprazole Impurity 2 Pantoprazole Impurity 2
rac-Valsartan EP Impurity B rac-Valsartan EP Impurity B 1894176-44-3 C31H35N5O3
Sitafloxacin Dechloro Impurity Sitafloxacin Dechloro Impurity
Ticagrelor Related Compound 85 Ticagrelor Related Compound 85 1628340-74-8 C28H34F2N6O5S
Valsartan Impurity 12 Valsartan Impurity 12 1189547-11-2 C11H21NO3
Vonoprazan Impurity 17 Vonoprazan Impurity 17
Avibactam Impurity B Avibactam Impurity B
Brexpiprazole Impurity L Brexpiprazole Impurity L
Cefaclor Impurity 4 Cefaclor Impurity 4
Linagliptin Impurity 38 Linagliptin Impurity 38 1979144-52-9 C20H17ClN6O2
Pidotimod Impurity N Pidotimod Impurity N 1538596-97-2 C15H23N5O2S
Pitavastatin (3S,5S)-Isomer Ethyl Ester Pitavastatin (3S,5S)-Isomer Ethyl Ester
Pramipexole Impurity 3 Pramipexole Impurity 3
Rupatadine Impurity A Rupatadine Impurity A
Sulpiride Impurity 2 Sulpiride Impurity 2
Tenofovir Impurity 55 Tenofovir Impurity 55 1244422-52-3 C17H12Cl3NO3
Voriconazole Impurity F Voriconazole Impurity F
MEDICARPIN-3-O-GLUCOSIDE MEDICARPIN-3-O-GLUCOSIDE 52766-70-8 C22H24O9
Atorvastatin Impurity F Atorvastatin Impurity F 1371615-56-3 C66H68CaF2N4O10
Ambroxol  Impurity 8(Ambroxol  Impurity M) Ambroxol Impurity 8(Ambroxol Impurity M) 1445719-53-8 C13H16Br2N2O
1,4-di(benzo[b]thiophen-4-yl)piperazine 1,4-di(benzo[b]thiophen-4-yl)piperazine 1420987-86-5 C20H18N2S2
(1R,3S)-(3-Aminocyclopentyl) methanol (1R,3S)-(3-Aminocyclopentyl) methanol 117957-62-7 C6H13NO
2-[[6-[(3R)-3-tert-butoxycarbonylamino-1-piperidinyl]-3,4-dihydro-2,4-dioxo-3-methyl-1(2H)-pyrimidinyl]methyl]benzonitrile 2-[[6-[(3R)-3-tert-butoxycarbonylamino-1-piperidinyl]-3,4-dihydro-2,4-dioxo-3-methyl-1(2H)-pyrimidinyl]methyl]benzonitrile 1246610-74-1 C23H29N5O4
Canagliflozin Impurity 12 Canagliflozin Impurity 12
Canagliflozin Impurity G Canagliflozin Impurity G
Dolutegravir Impurity 1 Dolutegravir Impurity 1
Empagliflozin impurity F Empagliflozin impurity F
Ibrutinib Impurity 12 Ibrutinib Impurity 12
Nintedanib impurity J Nintedanib impurity J 1139457-10-5 C23H17N3O5
DSKNHVUKATXSCQ-GDVCOKDOSA-N DSKNHVUKATXSCQ-GDVCOKDOSA-N 188915-50-6 C14H14ClN3O4S
Clarthromycin EP Impurity B Clarthromycin EP Impurity B 299409-85-1 C37H67NO13
(4-Chloro-3-trifluoromethyl-phenyl)-carbamic acid tert-butyl ester (4-Chloro-3-trifluoromethyl-phenyl)-carbamic acid tert-butyl ester 352277-93-1 C12H13ClF3NO2
Brexpiprazole Impurity 15 Brexpiprazole Impurity 15
Edoxaban Impurity 16 Edoxaban Impurity 16 480450-69-9 C14H25N5O3
Rivaroxaban Impurity 24 Rivaroxaban Impurity 24
Ticagrelor Ticagrelor 1265919-24-1 C12H21NO5
Clindamycin (2R-cis)-Diastereomer Clindamycin (2R-cis)-Diastereomer 1440605-46-8 C18H33ClN2O5S
Genistein 7,4'-di-O-β-D-glucopyranoside Genistein 7,4'-di-O-β-D-glucopyranoside 36190-98-4 C27H30O15
Aprepitant Impurity 3 Aprepitant Impurity 3
Cabozantinib Impurity F Cabozantinib Impurity F
Cefmetazole sodium Impurity 7 Cefmetazole sodium Impurity 7 60638-57-5 C11H14N6O4S2
Tadalafil EP Impurity I Tadalafil EP Impurity I
1,4'-Bipiperidine, 1'-(phenylmethyl)- 1,4'-Bipiperidine, 1'-(phenylmethyl)- 116269-53-5 C17H26N2
[2-(4-Methoxyphenyl)-1-methylethyl]-formamide [2-(4-Methoxyphenyl)-1-methylethyl]-formamide 126002-14-0 C11H15NO2
Indacaterol Impurity 7 Indacaterol Impurity 7 1403389-05-8 C24H30N2O3
tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate 1883672-48-7 C29H38ClN7O4
1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-7-fluoro-6,8-dimethoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C15H14FNO5
cis-cyclo(Pro-Pro) cis-cyclo(Pro-Pro) 19943-27-2 C10H14N2O2
Ropivacaine-cycle Ropivacaine-cycle 1945965-95-6 C17H24N2O
4-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 4-(5-methyl-4-phenylisoxazol-3-yl)benzenesulfonamide 181696-12-8 C16H14N2O3S
Bupivacaine  Impurity Bupivacaine Impurity 2125995-27-7 C18H28N2O.ClH
Brexpiprazole  Impurity Brexpiprazole Impurity 2059954-32-2 C17H21Cl2NO2
BDJS-SH 2 BDJS-SH 2 36585-31-6 C12H18N2O2
Acyclovir Impurity Q Acyclovir Impurity Q
Ampicillin EP Impurity M Ampicillin EP Impurity M 114977-84-3 C48H57N9O12S3
Aprepitant Impurity 12 Aprepitant Impurity 12 172673-23-3 C23H21F7N4O4
Aprepitant Impurity 18 Aprepitant Impurity 18
Blonanserin impurity D Blonanserin impurity D
Captopril impurity 3 Captopril impurity 3
Empagliflozin Impurity 18 Empagliflozin Impurity 18
Cefdinir impurity PQ mixture Cefdinir impurity PQ mixture
Loratadine Impurity 16 Loratadine Impurity 16 C22H23ClN2O2
Meptazinol BP Impurity D Meptazinol BP Impurity D 1883577-02-3 C30H44N2O
Prasugrel Impurity 12 Prasugrel Impurity 12
Pregabalin Impurity 16 Pregabalin Impurity 16
PSI-7977-13C-d3 PSI-7977-13C-d3 2070009-25-3 C22H26D3FN3O9P
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