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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
Levocarnitine EP Impurity A(Z) Levocarnitine EP Impurity A(Z)
Penicillin impurity E Penicillin impurity E
2-bromo-6-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile 2-bromo-6-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzonitrile
tert-butyl 2-((4R,6S)-6-((E)-2-(4-(2-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-((E)-2-(4-(2-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate
methyl (3aR,4S,6R,6aS)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3- yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate methyl (3aR,4S,6R,6aS)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3- yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo-, hydrochloride (1:) 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo-, hydrochloride (1:) 570403-05-3 C23H26Cl3N5O2S2
Avatrombopag Impurity 49 Avatrombopag Impurity 49
Avatrombopag Impurity 56 Avatrombopag Impurity 56
Pterosin A-2-O-glucoside Pterosin A-2-O-glucoside
2-(4-(2-(4-(1-(2-hydroxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid 2-(4-(2-(4-(1-(2-hydroxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid C26H33N3O3
3-(2-Aminoethyl)-N-methyl-1H-indole-5-methanesulfonamide 3-(2-Aminoethyl)-N-methyl-1H-indole-5-methanesulfonamide 88919-22-6 C12H17N3O2S
3'-Epi Gemcitabine 3'-Epi Gemcitabine 103882-85-5 C9H11F2N3O4
4-Chloro-6,7-bis-(2-chloroethoxy)quinazoline 4-Chloro-6,7-bis-(2-chloroethoxy)quinazoline 183322-21-6 C12H11Cl3N2O2
4-Hydroxy Omeprazole 4-Hydroxy Omeprazole 301669-82-9 C16H17N3O3S
Olodaterol Impurity 27 Olodaterol Impurity 27
(R)-Fluvastatin EP Impurity E (R)-Fluvastatin EP Impurity E
Ethacridine Impurity 9 Ethacridine Impurity 9
isopropyl 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate isopropyl 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate
FENOFIBRIC ACID ETHYL ESTER FENOFIBRIC ACID ETHYL ESTER 42019-08-9 C19H19ClO4
Peonidin-3-O-Sophoroside-
5-O-β-D-glucoside Peonidin-3-O-Sophoroside- 5-O-β-D-glucoside 81360-22-7 C34H43O21+
7-ADCA Impuirty 1 7-ADCA Impuirty 1
1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1h-1,2,4-triazole 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1h-1,2,4-triazole 86386-76-7 C11H9F2N3O
Bisoprolol Impurity 34 Bisoprolol Impurity 34
Flomoxef Impurity I Flomoxef Impurity I
32,50-Dicarboxy-cyanoco balamin 32,50-Dicarboxy-cyanoco balamin
Olodaterol Impurity 30 Olodaterol Impurity 30
Avatrombopag Impurity 55 Avatrombopag Impurity 55 1039808-70-2 C14H16Cl2N2O3
Benzonitrile, 2-[[4-[(3R)-3-amino-1-piperidinyl]-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl]methyl]- Benzonitrile, 2-[[4-[(3R)-3-amino-1-piperidinyl]-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl]methyl]- 1634664-96-2 C17H19N5O2
2-(3,4-dihydroxyphenyl)-2-hydroxy-acetaldehyde 2-(3,4-dihydroxyphenyl)-2-hydroxy-acetaldehyde 13023-73-9 C8H8O4
3-Desmethyl Istradefylline 3-Desmethyl Istradefylline 155272-04-1 C19H22N4O4
BRN 0758154 BRN 0758154 69304-48-9 C11H13IN2O5
NSC4751 NSC4751 5393-61-3 C10H10N2O2
Sts 64 Sts 64 24284-84-2 C21H27NO2
2-hydroxy-N-[3-[3-(1-piperidylmethyl)phenoxy]propyl]acetamide 2-hydroxy-N-[3-[3-(1-piperidylmethyl)phenoxy]propyl]acetamide 97900-88-4 C17H26N2O3
Benazepril Related Compound D Benazepril Related Compound D 1347874-67-2 C22H25ClN2O5
2-Cyclopentene-1-carboxylicacid,4-amino-,methylester,(1R,4S)-(9CI) 2-Cyclopentene-1-carboxylicacid,4-amino-,methylester,(1R,4S)-(9CI) 352226-74-5 C7H11NO2
	Tamsulosin N- methyl benzyl Impurity Tamsulosin N- methyl benzyl Impurity
Oprinone Impurity 7 Oprinone Impurity 7
Arbidol Impurity 27 Arbidol Impurity 27
N-methyl-5,6-dihydroxyindole N-methyl-5,6-dihydroxyindole 4821-00-5 C9H9NO2
Imimidistine impurity G Imimidistine impurity G
4-amino-5-chloro-2-ethoxy-N-((2-morpholinyl)methyl)benzamide 4-amino-5-chloro-2-ethoxy-N-((2-morpholinyl)methyl)benzamide 152013-26-8 C14H20ClN3O3
cleistanthin B cleistanthin B 30021-77-3 C27H26O12
lumelysergol lumelysergol 7079-87-0 C16H20N2O2
columbianetin glucopyranoside columbianetin glucopyranoside 55836-35-6 C20H24O9
5'-deoxypyridoxine 5'-deoxypyridoxine 4811-03-4 C8H11NO2
10-deazaaminopterin 10-deazaaminopterin 52454-37-2 C20H21N7O5
phosphoric acid phosphoric acid 790712-60-6 C16H18F6N5O5P
4-(4-AMINO-3-FLUOROPHENOXY)-N-METHYLPICOLINAMIDE 4-(4-AMINO-3-FLUOROPHENOXY)-N-METHYLPICOLINAMIDE 757251-39-1 C13H12FN3O2
3-Bromo-5-chloropyrazine-2-carbonitrile 3-Bromo-5-chloropyrazine-2-carbonitrile 440124-25-4 C5HBrClN3
4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one (Loratadine Impurity) 4,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one (Loratadine Impurity) 133330-60-6 C14H9Cl2NO
Hydroxy Varenicline Hydroxy Varenicline 357424-21-6 C13H13N3O
ethyl (2S)-pyrrolidine-2-carboxylate ethyl (2S)-pyrrolidine-2-carboxylate 5817-26-5 C7H13NO2
[2R-[2aR*),3a]-2-[1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine [2R-[2aR*),3a]-2-[1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine 170729-79-0 C20H18F7NO2
2-(5-Acetyl-2-ethoxyphenyl)-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4(1H)-one 2-(5-Acetyl-2-ethoxyphenyl)-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4(1H)-one 358390-43-9 C19H22N4O3
Olopatadine Ethyl Ester Olopatadine Ethyl Ester 113806-03-4 C23H27NO3
Empagliflozin Impurity 80 Empagliflozin Impurity 80
Empagliflozin Impurity 92 Empagliflozin Impurity 92
Iohexol Impurity N Iohexol Impurity N
Pitavastatin 5-Oxo Impurity  Calcium Salt Pitavastatin 5-Oxo Impurity Calcium Salt 2180095-22-9 C25H24CaFNO4
1-(2-bromo-3,5-dihydroxyphenyl)ethanone 1-(2-bromo-3,5-dihydroxyphenyl)ethanone 2092614-65-6 C8H7BrO3
Lenvatinib impurity LFZZ-18 Lenvatinib impurity LFZZ-18 C11H8Cl2N2O2
Rosuvastatin Impurity 121 Rosuvastatin Impurity 121 140164-51-8 C10H18O5
Brivaracetam Impurity 38 Brivaracetam Impurity 38
Isavuconazole Impurities 04 Isavuconazole Impurities 04
Ticagrelor Impurity 119 Ticagrelor Impurity 119
Ticagrelor Impurity 118 Ticagrelor Impurity 118
D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-, acetate (9CI) D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)-, acetate (9CI) 402508-35-4 C11H18O6
L-Alanine, 3-[(S)-(carboxymethyl)sulfinyl]- L-Alanine, 3-[(S)-(carboxymethyl)sulfinyl]- 112246-66-9 C5H9NO5S
2-Propanone, 1-[4,5-dihydro-2-(4-methyl-1-piperazinyl)-4-thioxo-3H-1,5-benzodiazepin-3-ylidene]- 2-Propanone, 1-[4,5-dihydro-2-(4-methyl-1-piperazinyl)-4-thioxo-3H-1,5-benzodiazepin-3-ylidene]- 1902955-67-2 C17H20N4OS
3(2H)-Pyridazinone, 6-[4-(ethylamino)phenyl]-4,5-dihydro-5-methyl- 3(2H)-Pyridazinone, 6-[4-(ethylamino)phenyl]-4,5-dihydro-5-methyl- 52240-42-3 C13H17N3O
Benzoic acid, 4-[[4-(aminocarbonyl)-1-piperidinyl]methyl]- Benzoic acid, 4-[[4-(aminocarbonyl)-1-piperidinyl]methyl]- 938143-02-3 C14H18N2O3
1-(4-methylbenzyl)-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride 1-(4-methylbenzyl)-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride
2,4-bis(1-(2,3-dimethylphenyl)ethyl)-1H-imidazole 2,4-bis(1-(2,3-dimethylphenyl)ethyl)-1H-imidazole
2-((4R,6S)-6-((2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetoxy)methyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2-((4R,6S)-6-((2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetoxy)methyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid
1,3-bis(4-((E)-3-methoxy-3-oxoprop-1-en-1-yl)benzyl)-1H-imidazol-3-ium bromide 1,3-bis(4-((E)-3-methoxy-3-oxoprop-1-en-1-yl)benzyl)-1H-imidazol-3-ium bromide
1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[[(3-carboxyphenyl)amino]carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[[(3-carboxyphenyl)amino]carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)- 1401451-19-1 C40H36N6O14S2
Benzeneacetic acid, α-(hydroxymethyl)-, 9-butyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl ester, [7(S)-(1α,2β,4β,5α,7β)]- (9CI) Benzeneacetic acid, α-(hydroxymethyl)-, 9-butyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl ester, [7(S)-(1α,2β,4β,5α,7β)]- (9CI) 14861-14-4 C20H27NO4
Avatrombopag Impurity 32 Avatrombopag Impurity 32
Cisatracurium besylate impurity 18 Cisatracurium besylate impurity 18
Paclitaxel Impurity1 ABCDEFGHJKL Paclitaxel Impurity1 ABCDEFGHJKL
3-THIOPHENEPROPANAMINE, N,N-DIMETHYL-GAMMA-(1-NAPHTHALENYLOXY)-, ETHANEDIOATE(1:1) 3-THIOPHENEPROPANAMINE, N,N-DIMETHYL-GAMMA-(1-NAPHTHALENYLOXY)-, ETHANEDIOATE(1:1) 116817-26-6 C21H23NO5S
(2R,3S/2S,3R)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (2R,3S/2S,3R)-2-(2,4-Difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol 182230-43-9 C16H14F3N5O
Bumetanide Impurity 8 Bumetanide Impurity 8
Benzenesulfonamide, N-(2-aminoethyl)-3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxy- Benzenesulfonamide, N-(2-aminoethyl)-3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxy- 448184-52-9 C19H26N6O4S
Avibactam Impurity 04 Avibactam Impurity 04
Latamoxef Impurity C Latamoxef Impurity C
Carbamic acid, [2-hydroxy-1-methyl-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester, [R-(R*,S*)]- (9CI) Carbamic acid, [2-hydroxy-1-methyl-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester, [R-(R*,S*)]- (9CI) 31301-86-7 C24H25NO4
9H-Purine-9-ethanol, 6-amino-β-methyl- 9H-Purine-9-ethanol, 6-amino-β-methyl- 20776-34-5 C8H11N5O
2-amino-5-[(3,4,5-trimethoxyphenyl)methyl]-1H-pyrimidin-4-one 2-amino-5-[(3,4,5-trimethoxyphenyl)methyl]-1H-pyrimidin-4-one 92440-76-1 C14H17N3O4
Edoxaban impurity ABCDEFGHJKL Edoxaban impurity ABCDEFGHJKL
(S)-3-(3-((3-chloro-2-(3,4-dimethoxyphenyl)propyl)(methyl)amino) propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one hydrochloride (S)-3-(3-((3-chloro-2-(3,4-dimethoxyphenyl)propyl)(methyl)amino) propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-benzo[d]azepin-2-one hydrochloride
(2R,3R)-3-amino-2-methyl-4-oxoazetidine-1-sulfonic acid (2R,3R)-3-amino-2-methyl-4-oxoazetidine-1-sulfonic acid
Osimertinib impurity01 Osimertinib impurity01
(±)-N-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide monohydrochloride (±)-N-[3-acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide monohydrochloride 73899-76-0 C16H25ClN2O4
Hexanoic acid, 6-chloro-3,5-dihydroxy-, (3R,5S)- Hexanoic acid, 6-chloro-3,5-dihydroxy-, (3R,5S)- 958358-67-3 C6H11ClO4
Oseltamivir  Impurity 78 Oseltamivir Impurity 78
Oseltamivir  Impurity 67 Oseltamivir Impurity 67
Ixazomib Impurity ABCDEFGHJKL Ixazomib Impurity ABCDEFGHJKL
2-[[[4-(2,2-dimethyl-1-oxopropoxy)phenyl]sulfonyl]amino]-Benzoic acid 2-[[[4-(2,2-dimethyl-1-oxopropoxy)phenyl]sulfonyl]amino]-Benzoic acid 188114-98-9 C18H19NO6S
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