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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
ethyl N-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)Methyl)-N-pentanoyl-L-valinate ethyl N-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)Methyl)-N-pentanoyl-L-valinate 1111177-30-0 C26H33N5O3
Rosuvastatin EP impurity A Rosuvastatin EP impurity A 1714147-50-8 C25H34FN3NaO7S*
4-(3,4-DICHLOROPHENYL)-3,4-DIHYDRO-2H-NAPHTHALEN-1-ONE OXIME 4-(3,4-DICHLOROPHENYL)-3,4-DIHYDRO-2H-NAPHTHALEN-1-ONE OXIME 152642-35-8 C16H13Cl2NO
3-Pyridinecarboxylic acid, 6-(4-carboxy-1-piperidinyl)-5-chloro- 3-Pyridinecarboxylic acid, 6-(4-carboxy-1-piperidinyl)-5-chloro- 958457-83-5 C12H13ClN2O4
Linagliptin Impurity C Linagliptin Impurity C
Parecoxib Impurity B Parecoxib Impurity B
Vildagliptin impurity E Vildagliptin impurity E
3-propylisobenzofuran-1(3H)-one 3-propylisobenzofuran-1(3H)-one 72424-08-9 C11H12O2
Axitinib Sulfonyl Axitinib Sulfonyl 1348536-59-3 C22H18N4O3S
Atracurium Impurity B Atracurium Impurity B 87046-74-0
(R)-4-fluoro-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile (R)-4-fluoro-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile C23H24FN7O4
2-(2-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol 2-(2-fluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol C13H13FN6O
Dapagliflozin Impurity 10 Dapagliflozin Impurity 10 960404-86-8 C21H25ClO7
Ibrutinib Impurity 6 Ibrutinib Impurity 6 1917333-91-5 C28H26N6O3
Imatinib Impurity 5 Imatinib Impurity 5
Mirabegron Impurity 8 HCl Mirabegron Impurity 8 HCl 1684452-81-0 C21H24N4O2S
Regorafenib Impurity 2 Regorafenib Impurity 2
Vonoprazan Impurity 5 Vonoprazan Impurity 5
1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine 1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine 332374-42-2 C14H20N2O4S
Bendamustine Bendamustine 1219709-86-0 C14H18ClN3O2
Dapagliflozin Impurity E Dapagliflozin Impurity E
Febuxostat Impurity 14 Febuxostat Impurity 14 1335202-60-2 C15H16N2OS
Kaempferol 3-robinoside 7-glucoside Kaempferol 3-robinoside 7-glucoside 114924-89-9 C33H40O20
Vitexin 7-glucoside Vitexin 7-glucoside 35109-95-6 C27H30O15
2-amino-9-((1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 2-amino-9-((1S,3S,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one 1367369-77-4 C12H15N5O3
Carfilzomib Impurity B Carfilzomib Impurity B
Hesperidin dihydrochalcone Hesperidin dihydrochalcone 35573-79-6 C28H36O15
Alogliptin Imp.12 Alogliptin Imp.12 2749281-73-8 C25H25N5O3
Ornidazole Impurity 1 Ornidazole Impurity 1 1100750-18-2
Norpterosin B glucoside Norpterosin B glucoside 1226785-88-1 C19H26O7
Afatinib Impurity M Afatinib Impurity M
Ornidazole  Impurity Ornidazole Impurity 1100750-18-2
4-(3-nitrophenyl)-3-Morpholinone 4-(3-nitrophenyl)-3-Morpholinone 845729-43-3 C10H10N2O4
1,3-bis(2-chloroethyl)benzimidazolin-2-one 1,3-bis(2-chloroethyl)benzimidazolin-2-one 55470-74-1 C11H12Cl2N2O
Nintedanib Impurity A (Intedanib Impurity A ) Nintedanib Impurity A (Intedanib Impurity A )
2-Propanone, 1,3-bis(4-methoxyphenyl)- 2-Propanone, 1,3-bis(4-methoxyphenyl)- 29903-09-1 C17H18O3
Cefathiamidine Impurity D Cefathiamidine Impurity D
Cefazolin Impurity C (EP) Cefazolin Impurity C (EP)
Cefdinir Impurity H (CP) Cefdinir Impurity H (CP)
Cefdinir Impurity S(CP) Cefdinir Impurity S(CP)
Cefodizime oxidation Impurity 1 Cefodizime oxidation Impurity 1 111874-11-4 C20H20N6O7S4
Spectinomycin Impurity F Spectinomycin Impurity F
(7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium (7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium C29H38N5O10+
3-pentylisobenzofuran-1(3H)-one 3-pentylisobenzofuran-1(3H)-one 111943-62-5 C13H16O2
2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid 2036283-13-1 C10H10N4O3S2
Levofloxacin Impurity 18 Levofloxacin Impurity 18 138998-47-7 C14H13F4NO3
N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1) N-(5-amino-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide compound with methane (1:1)
N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide C18H17N5O
methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate 1616761-01-3 C17H23N5O3
Labetalol iMpurity Labetalol iMpurity 2731858-23-2
ZXANKCFSGFEBQW-PFEQFJNWSA-N ZXANKCFSGFEBQW-PFEQFJNWSA-N 1258938-54-3
TWEORVZIMOFLDE-MXTNKPTQSA-N TWEORVZIMOFLDE-MXTNKPTQSA-N 1706671-50-2 C25H31N5O9S
WGEFOIHAXGTXJE-RTMVWDMESA-N WGEFOIHAXGTXJE-RTMVWDMESA-N 1373171-12-0 C48H61NO14
ZIMIAPVHHUISPY-CLFYSBASSA-N ZIMIAPVHHUISPY-CLFYSBASSA-N 866954-86-1 C15H15F3O5
1-(4-AMinophenyl)-5,6-dihydro-3-(4-Morpholinyl)-2(1h)-pyridinone 1-(4-AMinophenyl)-5,6-dihydro-3-(4-Morpholinyl)-2(1h)-pyridinone 1267610-26-3 C15H19N3O2
Erlotinib IMpurity C Erlotinib IMpurity C 1312937-41-9 C15H20N2O5
Cinacalcet IMpurity Cinacalcet IMpurity 1229224-93-4 C22H26F3N
ApovincaMinic Acid Ethyl Ester N-Oxide ApovincaMinic Acid Ethyl Ester N-Oxide 109741-24-4 C22H26N2O3
PDXA-226 PDXA-226 352637-51-5 C14H14N2O
Ropivacaine-ET-R Ropivacaine-ET-R 98626-60-9 C16H24N2O
Ropivacaine-iPr-S Ropivacaine-iPr-S 265120-58-9 C17H26N2O
(S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine (S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine 1384080-33-4 C19H21NOS
methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate C17H15NO4S
Apremilast impurity 15 Apremilast impurity 15
Aprepitant Impurity 22 Aprepitant Impurity 22 934540-48-4 C20H16F7NO2
Aprepitant Impurity 9 Aprepitant Impurity 9 219821-37-1 C24H25F7N4O4
Betamethasone EP Impurity I Betamethasone EP Impurity I 185613-69-8 C22H29FO5
Canagliflozin Impurity 14 Canagliflozin Impurity 14 842133-17-9 C24H25FO5S
Carfilzomib Impurity F Carfilzomib Impurity F
Cefamandole Impurity A Cefamandole Impurity A 1947364-12-6 C17H16N2O6S
Dapagliflozin Impurity 19 Dapagliflozin Impurity 19 1469910-84-6 C29H33ClO10
Docetaxel EP Impurity A Docetaxel EP Impurity A
Empagliflozin Impurity 21 Empagliflozin Impurity 21
Febuxostat Impurity 43 Febuxostat Impurity 43
Formoterol Impurity 20 Formoterol Impurity 20
Hydroxychloroquine Impurity 2 Hydroxychloroquine Impurity 2
Ibrutinib Impurity 14 Ibrutinib Impurity 14 2417548-76-4 C50H48N12O4
Imatinib impurity 11 Imatinib impurity 11
Isavuconazole Impurity 2 Isavuconazole Impurity 2 2001051-99-4 C13H12F2N4O
Isavuconazole Impurity 25 Isavuconazole Impurity 25
Loxoprofen Impurity 18 Loxoprofen Impurity 18 99807-54-2 C11H13BrO2
Mupirocin EP Impurity D Mupirocin EP Impurity D 71087-97-3 C26H44O9
N-Acetyl-Lys-Octreotide N-Acetyl-Lys-Octreotide 173606-11-6 C51H68N10O11S2
Olaparib Impurity 3 Olaparib Impurity 3
Posaconazole Impurity 33 Posaconazole Impurity 33 182210-71-5 C12H13F2IO2
Posaconazole Impurity 38 Posaconazole Impurity 38
Posaconazole Impurity 62 Posaconazole Impurity 62
Roxithromycin Impurity J Roxithromycin Impurity J
Sitagliptin Impurity 21 Sitagliptin Impurity 21 2088771-60-0 C20H19F6N5O5
SofosBuvir Impurity 38 SofosBuvir Impurity 38
SofosBuvir Impurity 61 SofosBuvir Impurity 61
Suvorexant Impurity 2 Suvorexant Impurity 2 1276666-19-3 C23H23ClN6O2
Tenofovir impurity L Tenofovir impurity L
Ticagrelor Impurity 27 Ticagrelor Impurity 27 1402150-01-9 C19H26ClN5O5S
Ticagrelor impurity P Ticagrelor impurity P
Tramadol Impurity 1 Tramadol Impurity 1 66170-32-9 C16H25NO2
Lidocaine EP Impurity G Lidocaine EP Impurity G 42459-30-3 C13H20N2O
methyl 1,4-dihydroxy-7-phenoxyisoquinoline-3-carboxylate methyl 1,4-dihydroxy-7-phenoxyisoquinoline-3-carboxylate 1421312-32-4 C17H13NO5
1-(2,3-DIMETHYLPHENYL)PROPAN-1-OL 1-(2,3-DIMETHYLPHENYL)PROPAN-1-OL 944268-64-8 C11H16O
4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole 4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole 1448355-87-0 C16H12ClNO
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