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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
Quetiapine EP Impurity N Quetiapine EP Impurity N 1800291-86-4 C29H41N5O3S
Ceftazidime Impurity Ceftazidime Impurity
Chlorhexidine Digluconate Impurity N Chlorhexidine Digluconate Impurity N 152504-10-4 C15H25ClN8
S-Azetidin-3-yl ethanethioate HCl S-Azetidin-3-yl ethanethioate HCl 886615-18-5 C5H9NOS
Olaparib Impurity C Olaparib Impurity C
Olaparib Impurity F Olaparib Impurity F
Dapoxetine Impurity 4 Dapoxetine Impurity 4
Glycopyrrolate impurity 3 Glycopyrrolate impurity 3
Lamotrigine impurity B Lamotrigine impurity B
Ramosetron Impurity 3 Ramosetron Impurity 3
Loratadine Impurity 1 Loratadine Impurity 1 C22H23ClN2O2
Metoprolol IMpurity 6 Metoprolol IMpurity 6 C15H25NO3
Pitavastatin Impurity 5 Pitavastatin Impurity 5
Prasugrel Impurity C Prasugrel Impurity C
Trifluridine Impurity 2 Trifluridine Impurity 2
Cefazolin Impurity 4 Cefazolin Impurity 4
Vonoprazan Impurity 3 Vonoprazan Impurity 3
Cinacalcene Impurity I Cinacalcene Impurity I
Valsartan Impurity 2 Valsartan Impurity 2 C24H29N5O3
Istradefylline Impurity 2 Istradefylline Impurity 2
Etoricoxib Impurity 3 Etoricoxib Impurity 3
Apremilast Impurity 5 Apremilast Impurity 5 200710-04-9 C11H13NO4
Topiroxostat Imp.C Topiroxostat Imp.C
(3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(4-chlorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-08-7 C24H21ClFNO3
Rabeprazole Impurity 2 Rabeprazole Impurity 2 1163685-31-1 C11H15NO4
Regorafenib Impurity 8 Regorafenib Impurity 8
Flomoxef Impurity 5 Flomoxef Impurity 5 134237-56-2 C25H23ClF2N2O6S
Ranitidine  impurity Ranitidine impurity 94167-82-5 C10H18N2O
nicergoline impurity E nicergoline impurity E
ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate ethyl(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(4-ethoxy-4-oxobutanamido)-2-methylpentanoate C26H33NO5
Tacrolimus Impurity C Tacrolimus Impurity C
Levodopa impurity 5 Levodopa impurity 5
(R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide (R)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide 1223404-68-9 C21H22F2N6O2
Afatinib Impurity 18 Afatinib Impurity 18 2316847-95-5 C22H20ClFN4O4
Ivabradine Impurity 1 Hydrochloride Ivabradine Impurity 1 Hydrochloride 85175-52-6 C16H25ClN2O3
SofosBuvir Impurity 3 SofosBuvir Impurity 3
phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate phenyl (4-((6-carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)carbamate 417722-95-3 C24H18ClN3O5
Canagliflozin Impurity 10 Canagliflozin Impurity 10 1672658-93-3 C24H25FO6S
Canagliflozin Impurity F Canagliflozin Impurity F
Empagliflozin impurity E Empagliflozin impurity E
Fasudil Impurity 6 Fasudil Impurity 6 2044706-58-1 C11H11NO3S
Ibrutinib Impurity 11 Ibrutinib Impurity 11 C27H31N7O2
Nintedanib impurity I Nintedanib impurity I 334951-61-0 C30H31N5O4
(Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylic acid compound with 3-benzoyl-2-oxoindoline-6-carboxylic acid 1253768-91-0 C16H11NO4
Everolimus Related Compound 3 Everolimus Related Compound 3 147438-30-0 C32H49NO9
(R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate (R)-isopropyl 2-(((R)-(perfluorophenoxy)(phenoxy)phosphoryl)amino)propanoate 1627824-09-2 C18H17F5NO5P
Cefuroxime Sodium EP Impurity C Cefuroxime Sodium EP Impurity C 69822-88-4 C15H15N3O6S
Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid Acemetacin EP Impurity F/Carboxymethyl Acemetacin/[[[[[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetyl]oxy]acetic acid 76812-49-2 C23H20ClNO8
Cefuroxime Sodium EP Impurity G Cefuroxime Sodium EP Impurity G 97232-98-9 C17H17N3O8S
2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 2-chloro-4-(cyclopentylamino)-5-pyrimidinyl ethanone 1244949-62-9 C11H14ClN3O
Cetirizine 3-Chloro Impurity Cetirizine 3-Chloro Impurity 1232460-31-9 C21H25ClN2O3
Donepezil Impurity 8 Donepezil Impurity 8 1808997-65-0 C18H23NO4
Rivaroxaban Impurity 23 Rivaroxaban Impurity 23
(Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide (Z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamide 1450758-21-0 C5H6N4O2S
Metronidazole Impurity 2 Metronidazole Impurity 2
ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5- carboxylate 144060-84-4 C17H18N2O3S
Dasatinib Impurity 24 Dasatinib Impurity 24
Pregabalin Impurity 19 Pregabalin Impurity 19 89015-27-0 C11H14O3
Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside 56316-75-7 C28H24O16
Alogliptin Impurity 7 Alogliptin Impurity 7
Alogliptin Impurity 7 Alogliptin Impurity 7
diethyl 2-(2-bromoethyl)-malonate diethyl 2-(2-bromoethyl)-malonate 18721-64-7 C9H15BrO4
methyl 2,5-dihydroxybenzenesulfonate methyl 2,5-dihydroxybenzenesulfonate C7H8O5S
Pinocembroside,Pinocembrin41-O-beta-D-glucoside Pinocembroside,Pinocembrin41-O-beta-D-glucoside
4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 123441-05-4 C14H22N2O2
Dapagliflozin mono acetyl impurity Dapagliflozin mono acetyl impurity 1632287-34-3 C23H27ClO7
Piperacillin Impurity 3 Piperacillin Impurity 3
Varenicline Impurity 5 Varenicline Impurity 5 950781-87-0 C11H13N3O2
4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 30165-97-0 C6H9N3O2S
Amlodipine Impurity 29 Amlodipine Impurity 29 93848-82-9 C22H27ClN2O6
Amlodipine Impurity 34 Amlodipine Impurity 34 C26H31ClN2O8S
Axitinib N-Glucuronide (M7) Axitinib N-Glucuronide (M7)
1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 53877-76-2 C17H24N2
propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate 1112262-71-1 C39H45FN2O5
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- 58404-37-8 C23H28O7
TYRPHOSTIN AG 1290 TYRPHOSTIN AG 1290 160391-70-8 C10H6N2O6
N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide 926319-54-2 C13H19NO2
Cetirizine EP Impurity B(base) Cetirizine EP Impurity B(base) 942193-17-1 C19H21ClN2O2
Dezocine Impurity 3 Dezocine Impurity 3 100667-16-1 C16H21NO2
Ertapenem Impurity 10 Ertapenem Impurity 10 357154-27-9 C22H27N3O8S
loteprednol Impurity 8 loteprednol Impurity 8 207670-54-0 C24H29ClO7
Nimodipine Impurity 4 Nimodipine Impurity 4 74936-69-9 C18H20N2O6
Paroxetine Impurity 45 Paroxetine Impurity 45 1396174-70-1 C19H20FNO3
Tazobactam Impurity 5 Tazobactam Impurity 5 115546-67-3 C21H20ClNO3S
Tigecycline Impurity 2 Tigecycline Impurity 2 1422262-97-2 C29H39N5O8
Empagliflozin Impurity 34 Empagliflozin Impurity 34
Sugammadex Impurity 22 Sugammadex Impurity 22 2412952-94-2 C72H113NaO48S8
Febuxostat Febuxostat 1312815-36-3 C20H25NO4S
Itraconazole Impurity 34 Itraconazole Impurity 34 103661-14-9 C14H15Cl2N3O5S
Lansoprazole Impurity 34 Lansoprazole Impurity 34 1357726-93-2 C7H8N2O3
Meloxicam Impurity 1 HCl Meloxicam Impurity 1 HCl 929568-25-2 C4H7ClN2O
Palonosetron Impurity 11 Palonosetron Impurity 11 2216753-67-0 C18H24N2O
Dapagliflozin Impurity 10 Dapagliflozin Impurity 10 461432-27-9 C21H25ClO7
Levetiracetam impurity 2 Levetiracetam impurity 2 1341459-52-6 C8H17N3O2
(S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide (S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide 2204368-63-6 C23H21Cl2N3O5S2
4-Desmethyl 3-Methyl Vortioxetine Hydrochloride 4-Desmethyl 3-Methyl Vortioxetine Hydrochloride 1293343-01-7
OFLOXACIN N-OXIDE (MIXTURE OF DIASTEREOMERS) OFLOXACIN N-OXIDE (MIXTURE OF DIASTEREOMERS) 104721-52-0 C18H20FN3O5
4-[[2-(2-Amino-4-thiazolyl)acetyl]amino]-benzeneacetic Acid 4-[[2-(2-Amino-4-thiazolyl)acetyl]amino]-benzeneacetic Acid 1365244-64-9 C13H13N3O3S
Fosfomycin Trometamol impurity C Fosfomycin Trometamol impurity C 23001-39-0 C4H12NO6P
(R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate (R)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile oxalate C22H23FN2O5
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