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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
1-(3-Cyanopyridyl-2)-2-Phenyl-4-Methylpyperazine 1-(3-Cyanopyridyl-2)-2-Phenyl-4-Methylpyperazine 61337-88-0 C17H18N4
Ertapenem Impurity E(USP) Ertapenem Impurity E(USP)
O-Demethyl elagolix sodium O-Demethyl elagolix sodium 832720-51-1 C31H28F5N3O5
Pitavastatin Impurity 81 Pitavastatin Impurity 81
Carbazochrome Sodium Sulfonate Impurity IV (Carbazochrome Sodium Sulfonate Impurity 4) Carbazochrome Sodium Sulfonate Impurity IV (Carbazochrome Sodium Sulfonate Impurity 4)
Telmisartan EP Impurity B Complete Set Telmisartan EP Impurity B Complete Set
Atracurium Impurity G Complete Set Atracurium Impurity G Complete Set
Cetrorelix Impurity 12 Cetrorelix Impurity 12
Cetrorelix Impurity 5 (6-D-Orn) Cetrorelix Impurity 5 (6-D-Orn)
Tenofovir impurity EE Tenofovir impurity EE
Peramivir Intermediate Impurity 35 Peramivir Intermediate Impurity 35
Peramivir Intermediate Impurity 40 Peramivir Intermediate Impurity 40
Alvatrombopag Impurity 999 Alvatrombopag Impurity 999
Canagliflozin impurities 16 drops Canagliflozin impurities 16 drops
Palonosetron impurity 30XH Palonosetron impurity 30XH
Pazopanib ImpurityABCDEFGHJKL Pazopanib ImpurityABCDEFGHJKL
1-(4-(2-Dimethylamino)-2-ethoxyphenyl butanone 1-(4-(2-Dimethylamino)-2-ethoxyphenyl butanone 68047-07-4 C20H25NO2
Vonoprazan-050-C4H4O4 Vonoprazan-050-C4H4O4 928325-69-3 C21H19ClFN3O6S
Crisaborole Impurity 45 Crisaborole Impurity 45 1785498-37-4 C7H6Br2O
Sugammadex Impurity 26(Org199129-1) Sugammadex Impurity 26(Org199129-1) 2412953-06-9
Gadobutrol Impurity A Gadobutrol Impurity A
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
2-(4-ethylpiperazin-1-yl)-4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine 2-(4-ethylpiperazin-1-yl)-4-(4-methoxyphenyl)-5,6,7,8,9,10-hexahydrocycloocta[b]pyridine C24H33N3O
Rosuvastatin Impurity 163 Rosuvastatin Impurity 163
Rosuvastatin Impurity 150 Rosuvastatin Impurity 150
Roxadustat Impurity 15 Roxadustat Impurity 15
(1S,3S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H- pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,6,7,8,8a-octahydronaphthalen- 1-yl 2,2-dimethylbutanoate (1S,3S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H- pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,4,6,7,8,8a-octahydronaphthalen- 1-yl 2,2-dimethylbutanoate 132487-01-5 C25H40O5
3-(hydroxy(2-methyl-1H-imidazol-1-yl)methyl)-9-(hydroxymethyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-(hydroxy(2-methyl-1H-imidazol-1-yl)methyl)-9-(hydroxymethyl)-1,2,3,9-tetrahydro-4H-carbazol-4-one
Perospirone Impurity 18 Perospirone Impurity 18
Perospirone Impurity 3 Perospirone Impurity 3 1002359-81-0 C8H11NO2
Dolutegravir Impurity 13(Sodium Salt) Dolutegravir Impurity 13(Sodium Salt)
Paxlovid Impurity 10 Paxlovid Impurity 10
Fondaparinux sodium impurity 4 Fondaparinux sodium impurity 4
Ampicillin Impurity W Ampicillin Impurity W
Lasmiditan Impurity 5 Lasmiditan Impurity 5
Olodaterol Impurity 18 Olodaterol Impurity 18 2727170-18-3
Febuxostat impurity DAC Febuxostat impurity DAC
ETHYL1-METHYL-2-OXOCYCLOPENTANECARBOXYLATE ETHYL1-METHYL-2-OXOCYCLOPENTANECARBOXYLATE 5453-88-3 C9H14O3
Olodaterol Impurity 27 Olodaterol Impurity 27
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
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
(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
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
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
4-Methoxy-3-methyl-1-[6-(1H-pyrrol-1-yl)-1H-benzimidazol-2-yl]-2-(thiocyanatomethyl)pyridinium 4-Methoxy-3-methyl-1-[6-(1H-pyrrol-1-yl)-1H-benzimidazol-2-yl]-2-(thiocyanatomethyl)pyridinium 2285346-43-0 C20H18N5OS
Nemonoxacin Impurity 6 Nemonoxacin Impurity 6 2770004-80-1 C24H29N3O8
10-deazaaminopterin 10-deazaaminopterin 52454-37-2 C20H21N7O5
phosphoric acid phosphoric acid 790712-60-6 C16H18F6N5O5P
Cyclophosphamide impurity 30 Cyclophosphamide impurity 30 2924754-60-7
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
6-(5-Chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5H-pyrrolo[3,4-b]pyrazin-5-one 6-(5-Chloro-2-pyridyl)-6,7-dihydro-7-hydroxy-5H-pyrrolo[3,4-b]pyrazin-5-one 43200-81-3 C11H7ClN4O2
7-(4-Chlorobutoxy)-1H-quinolin-2-one 7-(4-Chlorobutoxy)-1H-quinolin-2-one 913613-82-8 C13H14ClNO2
-Oxo-a-propylenanthic Acid Ethyl Ester -Oxo-a-propylenanthic Acid Ethyl Ester 96610-56-9 C12H22O3
5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine 5'-Deoxy-5-fluoro-N-[(2-methylbutoxy)carbonyl]cytidine 910129-15-6 C15H22FN3O6
methyl 2,4-bis{2-nitrophenyl}-6-methyl-1,2,3,4-tetrahydro-5-pyrimidinecarboxylate methyl 2,4-bis{2-nitrophenyl}-6-methyl-1,2,3,4-tetrahydro-5-pyrimidinecarboxylate 108139-78-2 C19H18N4O6
2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 2α,3β,23-Trihydroxyolean-12-en-28-oic acid β-D-glucopyranosyl ester 62369-72-6 C36H58O10
10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 10-[3-(Dimethylamino)propyl]-10H-phenothiazine 5-oxide 146-21-4 C17H20N2OS
3,3'-((2,2'-bis(ethoxymethyl)-[1,1'-biphenyl]-4,4'-diyl)bis(methylene))bis(2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one) 3,3'-((2,2'-bis(ethoxymethyl)-[1,1'-biphenyl]-4,4'-diyl)bis(methylene))bis(2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one)
(2R,3R)-2-(4-(cyclopentylamino)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-methyl-3-(trifluoromethyl)phenyl)piperidine-3-carboxamide (2R,3R)-2-(4-(cyclopentylamino)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-methyl-3-(trifluoromethyl)phenyl)piperidine-3-carboxamide
(6E,10E)-7,11,15-Trimethyl-3-methylene-1,6,10,14-hexadecatetrene (6E,10E)-7,11,15-Trimethyl-3-methylene-1,6,10,14-hexadecatetrene 70901-63-2 C20H32
4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 68128-53-0 C19H33NO13
4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 4-O-[4-[[(1S)-4β,5α,6β-Trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1β-yl]amino]-4,6-dideoxy-α-D-glucopyranosyl]-D-glucose 68128-53-0 C19H33NO13
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