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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
Piperacillin Impurity N Piperacillin Impurity N
2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 26050-44-2 C10H15NO
Lenvatinib Impurity 35 Lenvatinib Impurity 35
Febuxostat Impurity 58 Febuxostat Impurity 58
Cefodizime Impurity B Cefodizime Impurity B
Cefodizime Impurity D Cefodizime Impurity D
Amlodipine Impurity 49 Amlodipine Impurity 49 79781-18-3 C18H18ClNO5
Penicillin Impurity B Penicillin Impurity B
4,4'-(1H-1,2,4-Triazol-1-ylmethylene)bis[benzoic acid] 4,4'-(1H-1,2,4-Triazol-1-ylmethylene)bis[benzoic acid] 1644566-39-1 C17H13N3O4
Cefminox Sodium impurity B Cefminox Sodium impurity B
Cefotiam Impurity B Cefotiam Impurity B
pranoprofen impurity 11 pranoprofen impurity 11 52549-44-7 C15H13NO4
Atorvastatin Calcium Hydrate impurity 32 Atorvastatin Calcium Hydrate impurity 32 2088732-01-6 C14H27NO4
Cefazolin Impurity 5 Cefazolin Impurity 5
Peramivir Impurity E Peramivir Impurity E
Lincomycin sulfoxide Impurity 3 Lincomycin sulfoxide Impurity 3
Lincomycin sulfoxide Impurity F Lincomycin sulfoxide Impurity F
Fasudil iMpurity F Fasudil iMpurity F
(S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile (S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile 914070-99-8 C7H11N3O
3-HYDROXY-THIOBENZAMIDE 3-HYDROXY-THIOBENZAMIDE 104317-54-6 C7H7NOS
Tadalafil impurity 38 Tadalafil impurity 38 185750-07-6 C14H15ClN2O3
Fulvestrant impurity H Fulvestrant impurity H
Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt 2122800-38-6 C13H19N2NaO3
1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 928615-46-7 C17H16FN3O2S
2-METHYLPYRAZINE 1,4-DIOXIDE 2-METHYLPYRAZINE 1,4-DIOXIDE 32046-26-7 C5H6N2O2
4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 247583-78-4 C8H14N4O
Bendamustine Related Impurity 2 Bendamustine Related Impurity 2
Bendamustine Related Impurity 7 Bendamustine Related Impurity 7
Bortezomib Impurity 25 Bortezomib Impurity 25
Bortezomib Impurity 40 Bortezomib Impurity 40
Edoxaban Impurity 28 (1R,2R,4R) Edoxaban Impurity 28 (1R,2R,4R) 1255529-38-4 C21H30ClN5O5
Linagliptin Impurity 31 Linagliptin Impurity 31
Olopatadine Impurity 1 Olopatadine Impurity 1 66801-40-9 C15H10O4
Paroxetine Impurity 12 Paroxetine Impurity 12
Rivaroxaban Impurity 69 DiHCl Rivaroxaban Impurity 69 DiHCl
Sitafloxacin Impurity 5 Sitafloxacin Impurity 5 1630983-99-1 C15H12ClF4NO3
Ticagrelor Related Compound 92 Ticagrelor Related Compound 92
Valsartan Impurity 10 Valsartan Impurity 10 1314799-74-0 C23H29N5O
Vonoprazan Impurity 23 Vonoprazan Impurity 23
Adefovir Impurity 1 Adefovir Impurity 1
Bendamustine Impurity G Bendamustine Impurity G
Blonanserin Impurity K Blonanserin Impurity K
Brexpiprazole Impurity F Brexpiprazole Impurity F
Cefazolin USP Impurity D Cefazolin USP Impurity D
Cefuroxime Impurity 9 Cefuroxime Impurity 9 2165460-37-5 C8H10N2O4S
Everolimus Impurity E Everolimus Impurity E
Peramivir Impurity 3 Peramivir Impurity 3
Peramivir Impurity 8 Peramivir Impurity 8
Pitavastatin Impurity 13 Pitavastatin Impurity 13
Pramipexole Impurity R Pramipexole Impurity R
Tadalafil Impuirty 21 Tadalafil Impuirty 21
1-cyclopropyl-8-ethoxy-6-fluoro-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-8-ethoxy-6-fluoro-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride 2252446-70-9 C22H27ClFN3O4
Doxofylline iMpurity E Doxofylline iMpurity E
Mupirocin Impurity 3 Mupirocin Impurity 3 C26H44O9
(1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid (1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid 220352-36-3 C10H8F2O2
Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate 202534-94-9 C15H16FNO4
Tofacitinib Impurity H Tofacitinib Impurity H
3',6'-Dehydroclindamycin 3',6'-Dehydroclindamycin 1440605-51-5 C18H31ClN2O5S
Iguratimod Impurity 5 Iguratimod Impurity 5 84594-95-6 C13H11NO4
Cefradine Impurity F Cefradine Impurity F
Mirabegron Impurity Mirabegron Impurity 1684452-83-2 C26H28N6O3S2
1-methyl-1H-indol-6-ol 1-methyl-1H-indol-6-ol 130570-60-4 C9H9NO
2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 118485-48-6 C13H13NO3S
32-Carboxycyanocobalamin 32-Carboxycyanocobalamin 121483-62-3 C63H87CoN13O15P
Alvimopan Impurity 6 Alvimopan Impurity 6
Acarbose Impurity B Acarbose Impurity B
Sofosbuvir Impurity28 Sofosbuvir Impurity28
Rivaroxaban Impurity 10 Rivaroxaban Impurity 10
Ipragliflozin Impurity 1 Ipragliflozin Impurity 1
(17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile (17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile 98149-13-4 C20H24BrNO2
316173-27-0 316173-27-0 316173-27-0 C17H28N2O5
Azilsartan Impurity Azilsartan Impurity 1821386-21-3 C22H18N4O4
Irbesartan Impurity 7 Irbesartan Impurity 7 C25H28N6O
Voriconazole Impurity 2 Voriconazole Impurity 2
1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 155272-03-0 C18H20N4O4
Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- 181289-34-9 C9H17NO3
Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide 2614-10-0 C11H14N2O4
4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 65141-48-2 C8H10N4O7
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 69321-95-5 C9H12N2O7
2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 91219-90-8 C11H15NO3
4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 4,4'-(4H-1,2,4-TRIAZOL-4-YLMETHYLENE)BIS BENZONITRILE 112809-52-6 C17H11N5
Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- Pregna-1,4,9(11)-triene-3,20-dione,21-(acetyloxy)-17-hydroxy-6-methyl-, (6a)- 93239-37-3 C24H30O5
Tadalafil EP impurity E Tadalafil EP impurity E
4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 4'-chloro-7H-4,7'-bipyrrolo[2,3-d]pyrimidine 134965-85-8 C12H7ClN6
myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside myricetin 3-O-β-D-xylopyranosyl(1-2)-β-D-glucopyranoside 142449-93-2 C26H28O17
MFFANMLJBOSKIX-UHFFFAOYSA-N MFFANMLJBOSKIX-UHFFFAOYSA-N 352457-34-2 C9H13N5O2
4,4',4''-Methylidenetrisbenzonitrile 4,4',4''-Methylidenetrisbenzonitrile 113402-31-6 C22H13N3
methyl (2E)-3-(methylamino)but-2-enoate methyl (2E)-3-(methylamino)but-2-enoate 21759-69-3 C6H11NO2
Entecavir Impurity 5 Entecavir Impurity 5 84868-56-4 C21H20O2
Bisoprolol-d5 Bisoprolol-d5 1189881-87-5 C18H31NO4
4-(2-HYDROXY-3-ISOPROPYLAMINO-PROPOXY)-BENZOIC ACID METHYL ESTER 4-(2-HYDROXY-3-ISOPROPYLAMINO-PROPOXY)-BENZOIC ACID METHYL ESTER 33947-97-6 C14H21NO4
5-METHYL-3-NITROMETHYL-HEXANOIC ACID 5-METHYL-3-NITROMETHYL-HEXANOIC ACID 181289-21-4 C8H15NO4
4(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENE AMINE RACEMATE 4(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-N-METHYL-1-NAPHTHALENE AMINE RACEMATE 140631-53-4 C17H17Cl2N
(3R,5R)-tert-butyl 7-(2,3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate (3R,5R)-tert-butyl 7-(2,3-bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate 2588261-40-7 C37H42F2N2O5
(S)-ethyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate (S)-ethyl 2-(4-hydroxy-2-oxopyrrolidin-1-yl)acetate 870695-39-9 C8H13NO4
4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-hydroxybenzyl)phthalazin-1(2H)-one 4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-hydroxybenzyl)phthalazin-1(2H)-one C24H24N4O4
Diquafosol Impurity 2 Diquafosol Impurity 2 63785-59-1 C18H25N4O20P3
N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2,2'-dichloro-N-methyl-7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-amine N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2,2'-dichloro-N-methyl-7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-amine 2459302-87-3 C26H26Cl2N8
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2,2-dichloroacetyl) -2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2,2-dichloroacetyl) -2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate 1598416-08-0 C22H18Cl2N2O5
PANTOPRAZOLE N-OXIDE SODIUM SALT PANTOPRAZOLE N-OXIDE SODIUM SALT 1279822-90-0 C16H16F2N3NaO5S
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