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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
Afatinib Impurity 50 Afatinib Impurity 50
Brexpiprazole Impurity 34 Brexpiprazole Impurity 34 2247155-42-4 C25H27N3O4S
Cabozantinib Impurity 5 Cabozantinib Impurity 5 104330-60-1 C11H12FNO3
Dronedarone Impurity 9 Dronedarone Impurity 9
Empagliflozin Impurity 58 Empagliflozin Impurity 58
Exemestane Impurity 6 Exemestane Impurity 6 14895-71-7
Gadobutrol Impurity 10 Gadobutrol Impurity 10
Linagliptin Impurity 55 Linagliptin Impurity 55
Oseltamivir Impurity 52 Oseltamivir Impurity 52
Palbociclib Impurity 65 Palbociclib Impurity 65
Pimecrolimus Impurity 1 Pimecrolimus Impurity 1
Rosuvastatin Impurity 99 Rosuvastatin Impurity 99
Terbutaline Impurity 18 Terbutaline Impurity 18
Ticagrelor Impurity 123 Ticagrelor Impurity 123
Tofacitinib Impurity 112 Tofacitinib Impurity 112 2179757-75-4 C12H19N3O2
Trelagliptin Impurity 42 Trelagliptin Impurity 42
Carbocistein Impurity E Carbocistein Impurity E
Tolvaptan Impurity 35 Tolvaptan Impurity 35 1316312-24-9 C10H10ClN
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
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
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
SORAFENIB N-OXIDE SORAFENIB N-OXIDE 583840-03-3 C21H16ClF3N4O4
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
(R)-N-Glycidylphthalimide (R)-N-Glycidylphthalimide 181140-34-1 C11H9NO3
6-chloro-N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-5- nitro-2-(propylthio)pyrimidin-4-amine 6-chloro-N-((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)-5- nitro-2-(propylthio)pyrimidin-4-amine 1427523-93-0 C16H15ClF2N4O2S
Bendamustine Impurity 15 Bendamustine Impurity 15
Bendamustine Related Impurity 10 Bendamustine Related Impurity 10
Bortezomib Impurity 16 Bortezomib Impurity 16
Captopril Related Compound 8 Captopril Related Compound 8 112243-88-6 C9H15NO3S
Edoxaban Impurity 25 (1R,2S,4R) Oxalate Edoxaban Impurity 25 (1R,2S,4R) Oxalate
Ezetimibe Impurity 35 Ezetimibe Impurity 35 1650568-82-3 C39H46F2N2O5Si2
Fosaprepitant Impurity 8 Fosaprepitant Impurity 8
Linagliptin Impurity 28 Linagliptin Impurity 28 2074688-84-7 C22H23N7O3
Pantoprazole Impurity 3 Pantoprazole Impurity 3
Ticagrelor Related Compound 58 Ticagrelor Related Compound 58
Vildagliptin Impurity 9 Vildagliptin Impurity 9
Cefathiamidine Impurity 5 Cefathiamidine Impurity 5 40818-86-8 C10H11ClN2O4S
methyl 4-hydroxy-3,5-diisopropylbenzoic acid methyl 4-hydroxy-3,5-diisopropylbenzoic acid C14H20O3
Apixaban Impurity J Apixaban Impurity J
替扎尼定EP雜質(zhì)C 替扎尼定EP雜質(zhì)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
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
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