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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
Crisaborole Impurity 8 Crisaborole Impurity 8
Trifluridine Impurity B Trifluridine Impurity B
Rotigotine Impurity Rotigotine Impurity
Olprinone Impurity 2 Olprinone Impurity 2 106730-62-5 C14H12N4O2
Nicorandil Impurity F Nicorandil Impurity F
Nicorandil Impurity A Nicorandil Impurity A
M-ISOBUTYL IBUPROFEN M-ISOBUTYL IBUPROFEN 66622-47-7 C13H18O2
1,3-BIS(METHYLTHIO)-2-PROPANOL 1,3-BIS(METHYLTHIO)-2-PROPANOL 31805-83-1 C5H12OS2
4-ISOTHIOCYANATO-4'-NITRODIPHENYL ETHER 4-ISOTHIOCYANATO-4'-NITRODIPHENYL ETHER 19881-18-6 C13H8N2O3S
Cefminox Sodium impurity 5 Cefminox Sodium impurity 5
SORAFENIB N-OXIDE SORAFENIB N-OXIDE 583840-03-3 C21H16ClF3N4O4
Tolvaptan Impurity 35 Tolvaptan Impurity 35 1316312-24-9 C10H10ClN
Erythromycin Impurity F Erythromycin Impurity F
Apixaban Impurity 39 Apixaban Impurity 39
Aztreonam Impurity 1 Aztreonam Impurity 1
Axitinib Impurity 1 Axitinib Impurity 1
Aprepitant Impurity 15 Aprepitant Impurity 15
Trelagliptin Impurity 17 Trelagliptin Impurity 17 865759-02-0 C17H20BrFN4O2
Dapoxetine Impurity 1 Dapoxetine Impurity 1 2825577-69-1
Regorafenib Impurity 15 Regorafenib Impurity 15 3083426-64-3
Flomoxef Impurity 2 Flomoxef Impurity 2
Varenicline Impurity 2 Varenicline Impurity 2
Topiroxostat Impurity 5 Topiroxostat Impurity 5
Everolimus Impurity 5 Everolimus Impurity 5
Ibrutinib Impurity 3 Ibrutinib Impurity 3
Canagliflozin Impurity 9 Canagliflozin Impurity 9
Clopidogrel Impurity 14 Clopidogrel Impurity 14 C15H14ClNO2S
Febuxostat Impurity 53 Febuxostat Impurity 53
Cefodizime Impurity C Cefodizime Impurity C
Riociguat IMpurtiy F Riociguat IMpurtiy F
Acrivastine Impurity 1 Acrivastine Impurity 1
Nifedipine impurity 10 Nifedipine impurity 10 10323-98-5 C13H13NO3
Cefminox Sodium impurity E Cefminox Sodium impurity E
Clindamycin Impurity D Clindamycin Impurity D
Fasudil iMpurity C Fasudil iMpurity C
Cefminox Impurity D Cefminox Impurity D
Ipragliflozin Impurity 6 Ipragliflozin Impurity 6
Ibrutinib Impurity 27 Ibrutinib Impurity 27 2031255-26-0 C26H28N6O3
Clopidogrel Impurity 59 Clopidogrel Impurity 59 1122047-98-6 C25H26ClNO6S
Ozagrel Impurity B Ozagrel Impurity B
Ceftriaxone Sodium impurity F Ceftriaxone Sodium impurity F
(R)-5-(2-fluoro-3-methoxyphenyl)-1-(2-fluoro-6-(trifluoromethyl)benzyl)-6-methyl-3-(2-(2-oxopyrrolidin-1-yl)-2-phenylethyl)pyrimidine-2,4(1H,3H)-dione (R)-5-(2-fluoro-3-methoxyphenyl)-1-(2-fluoro-6-(trifluoromethyl)benzyl)-6-methyl-3-(2-(2-oxopyrrolidin-1-yl)-2-phenylethyl)pyrimidine-2,4(1H,3H)-dione 2248628-93-3 C32H28F5N3O4
Famotidine EP Impurity I HCl Famotidine EP Impurity I HCl C8H15N7O2S3
Tizanidine EP Impurity C Tizanidine EP Impurity C 1147548-83-1 C16H14Cl2N10S2
nicergoline impurity Q nicergoline impurity Q
Loratadine Impurity 19 Loratadine Impurity 19 79779-58-1 C22H24N2O2
(Z)-2-chloro-3-hydroxyacrylaldehyde (Z)-2-chloro-3-hydroxyacrylaldehyde 50704-42-2 C3H3ClO2
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4''-fluoro-[1,1''-biphenyl]-4-yl)-1-methylpiperidine hydrochloride (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4''-fluoro-[1,1''-biphenyl]-4-yl)-1-methylpiperidine hydrochloride
Ticagrelor Related Compound 39 Ticagrelor Related Compound 39
Erlotinib Impurity 32 Erlotinib Impurity 32
Pramipexole Impurity 36 Pramipexole Impurity 36
Teneligliptin Impurity 3 Teneligliptin Impurity 3
Erlotinib Hydrochloride iMpurity 52 Erlotinib Hydrochloride iMpurity 52
Ornidazole Impurity J Ornidazole Impurity J 742020-47-9 C7H12N4O3
CHLORHEXIDENE DIACETATE IMPURITY A CHLORHEXIDENE DIACETATE IMPURITY A 152504-08-0 C16H24ClN9
Daidzein-4′-glucoside Daidzein-4′-glucoside 58970-69-7 C21H20O9
Aprepitant iMpurity 45 Aprepitant iMpurity 45
Afatinib Impurity 75 Afatinib Impurity 75 2348580-72-1 C7H14N2O
Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl) Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl) 159325-45-8 C23H35NO2
(2b,3a,16b,17b)-2,16-Bispiperidino-3,17-diacetoxy-5-androstane (2b,3a,16b,17b)-2,16-Bispiperidino-3,17-diacetoxy-5-androstane 13529-31-2 C33H54N2O4
Palbociclib Impurity 59 Palbociclib Impurity 59 1430196-98-7 C14H20N4O4
Landiolol impurity Z Landiolol impurity Z
Vitamin K1 Impurity 1 Vitamin K1 Impurity 1 19274-66-9 C31H46O2
Teneligliptin Impurity 13 Teneligliptin Impurity 13
Ceftazidime EP Impurity D Ceftazidime EP Impurity D 73547-69-0 C45H44N6O7S2
Nicergoline EP Impurity G Nicergoline EP Impurity G 57935-65-6 C23H24BrN3O2
Benzenesulfonamide, 4-[5-(4-methylphenyl)-2-oxido-3-(trifluoromethyl)-1H-pyrazol-1-yl]- Benzenesulfonamide, 4-[5-(4-methylphenyl)-2-oxido-3-(trifluoromethyl)-1H-pyrazol-1-yl]- 2356153-95-0 C17H14F3N3O3S
2-Pyrrolidinecarbonitrile, 1-(2-aminoacetyl)-, hydrochloride (1:1), (2S)- 2-Pyrrolidinecarbonitrile, 1-(2-aminoacetyl)-, hydrochloride (1:1), (2S)- 913980-23-1 C7H12ClN3O
Lamivudine Impurity 7 Lamivudine Impurity 7 147126-63-4 C14H24O4S
EsCitalopram EP Impurity I EsCitalopram EP Impurity I 1370643-22-3 C20H21FN2O
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine 127017-42-9 C21H25NO4
Methylprednisolone Impurity 21 Methylprednisolone Impurity 21 150899-33-5 C22H28O4
Epinephrine Impurity 7 Epinephrine Impurity 7 62322-82-1 C9H11NO3
(trans)-4-((2-amino-4,6-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-4,6-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
Fesoterodine Impurity 14 Fesoterodine Impurity 14
Dexamethasone EP impurities E Dexamethasone EP impurities E
(R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide (R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide C11H21BrN2O2
Empagliflozin Impurity 57(R,R) Empagliflozin Impurity 57(R,R)
Azacitidine Impurity 37 Azacitidine Impurity 37 206269-46-7 C8H12N4O5
Aripiprazole peroxide degradation Impurity (MW:303Da) Aripiprazole peroxide degradation Impurity (MW:303Da)
Pramipexole Impurity Reference Pramipexole Impurity Reference
2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+ 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+
3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 100688-45-7 C13H14O4
Acetaminophen Impurity 14 Acetaminophen Impurity 14 1991204-56-8 C16H18N2O2
Ketoconazole Impurity 7 Ketoconazole Impurity 7 172032-21-2 C11H12Cl2O3
Rosuvastatin Impurity 59 Rosuvastatin Impurity 59
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide 5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Losartan Impurity 12 Losartan Impurity 12 727718-93-6 C22H22ClN9
benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride 1865726-28-8 C17H19NO4S
Glycopyrrolate Impurity 12 Glycopyrrolate Impurity 12 857353-41-4 C13H14O3
(4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide (4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide 4660-26-8 C22H22N2O8
Regorafenib Impurity 38 Regorafenib Impurity 38
Cefazolin Impurity 28 Cefazolin Impurity 28
4-Isobutylacetophenone (Ibuprofen impurity) 4-Isobutylacetophenone (Ibuprofen impurity)
Acarbose Impurity IV (JP) Acarbose Impurity IV (JP) C13H21NO7
(2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans
-cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside (2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans -cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside 773899-29-9 C35H36O14
Demethylagrimonolide 6-O-glucoside Demethylagrimonolide 6-O-glucoside 1257408-55-1 C23H26O10
Vonoprazan Impurity 57 Vonoprazan Impurity 57
Tafluprost Impurity 9 Tafluprost Impurity 9 2099033-66-4 C27H41NO8
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2253977-80-7 C27H36N2O6
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