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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
(2RS)-2-(4-ETHYLPHENYL)PROPANOIC ACID (2RS)-2-(4-ETHYLPHENYL)PROPANOIC ACID 3585-52-2 C11H14O2
2-PIPERAZINE-4-AMINO-6,7-DIMETHOXY QUINOLINE HYDROCHLORIDE 2-PIPERAZINE-4-AMINO-6,7-DIMETHOXY QUINOLINE HYDROCHLORIDE 84050-22-6 C14H20ClN5O2
NICERGOLINE IMP. D (EP): 5-BROMOPYRIDINE-3-CARBOXYLIC ACID NICERGOLINE IMP. D (EP): 5-BROMOPYRIDINE-3-CARBOXYLIC ACID
AMOXICILLIN TRIHYDRATE IMP. D (EP) AS SODIUM SALT:(4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]-CARBOXYMETHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID SODIUM SALT (PENICILLOICACIDS OF AMO AMOXICILLIN TRIHYDRATE IMP. D (EP) AS SODIUM SALT:(4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]-CARBOXYMETHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID SODIUM SALT (PENICILLOICACIDS OF AMO 1642629-94-4 C16H21N3O6S
4-CHLORO-6-(2-CHLORO-ETHOXY)-7-(2-METHOXY-ETHOXY)-QUINAZOLINE 4-CHLORO-6-(2-CHLORO-ETHOXY)-7-(2-METHOXY-ETHOXY)-QUINAZOLINE 183322-19-2 C13H14Cl2N2O3
sodium 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)-1-oxidopiperazin-1-yl)ethoxy)acetate sodium 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)-1-oxidopiperazin-1-yl)ethoxy)acetate
Brivaracetam Impurity 25 Brivaracetam Impurity 25 10547-88-3 C7H12O2
(S)-N-((R)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide (S)-N-((R)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide
Peramivir Impurity 19 Peramivir Impurity 19
Diquafosol Impurity 13 Diquafosol Impurity 13 211448-81-6 C18H28N4O29P6
Montelukast Sodium EP Impurity G Montelukast Sodium EP Impurity G 1428448-96-7 C35H37ClNNaO3S
Amifostine related impurities 2 Amifostine related impurities 2 17002-55-0 C8H21N3O
Oxacillin Impurity F Oxacillin Impurity F 5053-35-0 C19H19N3O4S2
Peramivir Impurity 30 Peramivir Impurity 30 2758048-79-0 C20H36N2O6
FUROSEMIDE IMPURITY A FUROSEMIDE IMPURITY A C12H11ClN2O5S
GLICLAZIDE IMPURITY F GLICLAZIDE IMPURITY F
ONDANSETRON IMPURITY D ONDANSETRON IMPURITY D
PERINDOPRIL IMPURITY A PERINDOPRIL IMPURITY A
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
S-(+)-O-DESMETHYL VENLAFAXINE S-(+)-O-DESMETHYL VENLAFAXINE 142761-12-4 C16H25NO2
1H-Imidazole-1-carboxylic acid, (1R)-2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-1-[[[(2R)-3-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-2-[(1H-imidazol-1-ylcarbonyl)oxy]propyl][4-(3-oxo-4-morpholinyl)phenyl]amino]methyl]ethyl ester 1H-Imidazole-1-carboxylic acid, (1R)-2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-1-[[[(2R)-3-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)-2-[(1H-imidazol-1-ylcarbonyl)oxy]propyl][4-(3-oxo-4-morpholinyl)phenyl]amino]methyl]ethyl ester 2097255-05-3 C40H34N8O10
Elagolix Sodium impurity5 Elagolix Sodium impurity5
Tadalafil Impurity 46 Tadalafil Impurity 46
(trans)-4-((2-amino-3,4-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-3,4-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
cefdinir cefdinir
ACICLOVIR, Impurity J ACICLOVIR, Impurity J
1H-Inden-1-amine, 2,3-dihydro-N-2-propen-1-yl- 1H-Inden-1-amine, 2,3-dihydro-N-2-propen-1-yl- 91639-43-9 C12H15N
Salbutamol impurity 42 Salbutamol impurity 42 18910-69-5 C14H23NO3
(E)-8-(3,4-dimethoxystyryl) (E)-8-(3,4-dimethoxystyryl)
tert-butyl (3R,5R)-7-((3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanamido)-3,5-dihydroxyheptanoate tert-butyl (3R,5R)-7-((3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanamido)-3,5-dihydroxyheptanoate
(+)-Mediresinol Di-O-β-D-glucopyranoside (+)-Mediresinol Di-O-β-D-glucopyranoside 88142-63-6 C33H44O17
(trans)-3-(4-((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl)butane-1,2,4-triol (trans)-3-(4-((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecan-1-yl)butane-1,2,4-triol
Cefdinir CP Impurity B Cefdinir CP Impurity B
Voriconazole Impurity 15 Voriconazole Impurity 15 321589-00-8 C22H19F4N7O
Fluconazole Impurity 2 Fluconazole Impurity 2
Imatinib EP Impurity D Chloride Imatinib EP Impurity D Chloride
Favipiravir Impurity Favipiravir Impurity
Vildagliptin Dione Impurity Vildagliptin Dione Impurity 1844894-70-7 C17H24N2O3
Adsorption of hydrogen sulfide Adsorption of impurities in water filter material Adsorption of hydrogen sulfide Adsorption of impurities in water filter material
Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate Citalopram impurity 9/Citalopram EP Impurity C Oxalate Salt/3-Oxo Citalopram Oxalate Salt/Citalopram Related Compound C Oxalate Salt/3-(3-Dimethylaminopropyl)-3-(4-fluorophenyl)-6-cyano-1(3H)-isobenzofuranone oxalate 1440961-11-4 C22H21FN2O6
1H-Pyrrole-3-carboxamide, 5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-N-(2-hydroxyethyl)-2,4-dimethyl- 1H-Pyrrole-3-carboxamide, 5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-N-(2-hydroxyethyl)-2,4-dimethyl- 2170562-55-5 C18H18FN3O3
Apixaban Impurity 70 Apixaban Impurity 70 1998079-14-3 C44H40N8O9
Favipiravir Impurity 14 Favipiravir Impurity 14 356783-49-8 C5HClFN3
Posaconazole Impurity 93 Posaconazole Impurity 93 165115-82-2 C19H19F2IO2
N-Dealkyl Flurazepam (Midazolam impurity) N-Dealkyl Flurazepam (Midazolam impurity)
4-((3-amino-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
AMIKACIN IMPURITY A AMIKACIN IMPURITY A
(E)-Ceftiofur (E)-Ceftiofur 120882-20-4 C19H17N5O7S3
Cefmetazole Impurity E Cefmetazole Impurity E
Azlocillin Opern-Ring Decarboxylation Impurity Azlocillin Opern-Ring Decarboxylation Impurity 99795-14-9 C19H25N5O5S
Cefotiam Impurity 1 Cefotiam Impurity 1 2243596-87-2 C18H23N9O4S3
Eribulin Impurity 3 Eribulin Impurity 3
(1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid (1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid 220352-36-3 C10H8F2O2
(S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile (S)-1-(2-Aminoacetyl)-pyrrolidine-2-carbonitrile 914070-99-8 C7H11N3O
1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea 1388858-78-3 C19H23FN2O2
1,4,7,10-Tetraazabicyclo[8.2.2]tetradecan-11-one 1,4,7,10-Tetraazabicyclo[8.2.2]tetradecan-11-one 220182-11-6 C10H20N4O
Ropivacaine EP Impurity D Ropivacaine EP Impurity D 98626-59-6 C16H24N2O
Bendamustine Impurity 16 Bendamustine Impurity 16 914626-65-6 C19H18N6O4
(S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine  hydrochloride (S)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine hydrochloride 959392-22-4 C18H19NOS
phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate 603996-87-8 C8H11NO2S
Aprepitant Impurity 23 Aprepitant Impurity 23
Canagliflozin impurity H Canagliflozin impurity H
Cefazolin Impurity 9 Cefazolin Impurity 9 1322626-65-2 C14H15N9O3S3
Dapagliflozin Impurity 20 Dapagliflozin Impurity 20 2040305-09-5 C29H33ClO10
Edaravone Impurity 10 Edaravone Impurity 10 710307-89-4 C10H12N2O2
Empagliflozin Impurity 23 Empagliflozin Impurity 23
Entecavir Impurity 3 Entecavir Impurity 3 1391053-94-3 C12H15N5O4
IBrutinib Impurity C IBrutinib Impurity C
Imatinib impurity 12 Imatinib impurity 12
Isavuconazole Impurity 20 Isavuconazole Impurity 20
Isavuconazole Impurity 26 Isavuconazole Impurity 26
Istradefylline impurity D Istradefylline impurity D
Leuprorelin EP Impurity F Leuprorelin EP Impurity F 1872435-00-1 C59H84N16O12
Linagliptin Impurity 40 Linagliptin Impurity 40
Minocycline N-Hydroxymethyl Impurity Minocycline N-Hydroxymethyl Impurity 1075240-33-3 C24H29N3O8
Mivacurium Chloride Impurity 3 Mivacurium Chloride Impurity 3 740777-60-0 C33H46NO9+
Mupirocin EP Impurity E Mupirocin EP Impurity E 71087-96-2 C26H44O9
N-Acetyl-Phe-Octreotide N-Acetyl-Phe-Octreotide 83795-61-3 C51H68N10O11S2
Nifuratel Impurity 7 Nifuratel Impurity 7
Norepinephrine EP Impurity D Norepinephrine EP Impurity D 1932110-67-2 C9H13NO3
Olaparib Impurity 4 Olaparib Impurity 4
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
3-HYDROXY-THIOBENZAMIDE 3-HYDROXY-THIOBENZAMIDE 104317-54-6 C7H7NOS
Tadalafil impurity 38 Tadalafil impurity 38 185750-07-6 C14H15ClN2O3
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