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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
Pramipexole Impurity M Pramipexole Impurity M
Premastast Impurity 2 Premastast Impurity 2
Peramivir Impurity 26 Peramivir Impurity 26
Peramivir Impurity 34 Peramivir Impurity 34
(S)-2-(1-azabicyclo[2.2.2]oct-3-yl)-2,4,5,6-tetrahydro-1H-benz[de]isoquinolin-1-one hydrochloride (S)-2-(1-azabicyclo[2.2.2]oct-3-yl)-2,4,5,6-tetrahydro-1H-benz[de]isoquinolin-1-one hydrochloride
Imatinib impurity BY Imatinib impurity BY
6β-Methylprednisolone 6β-Methylprednisolone 18462-27-6 C22H30O5
DEXTROMETHORPHAN N-OXIDE DEXTROMETHORPHAN N-OXIDE 1177494-18-6 C18H25NO2
1-[(2-CHLOROPHENYL)DIPHENYLMETHYL]-1H-PYRAZOLE 1-[(2-CHLOROPHENYL)DIPHENYLMETHYL]-1H-PYRAZOLE C22H17ClN2
AMOXICILLIN TRIHYDRATE IMP. C (EP): (4S)-2-[5-(4-HYDROXYPHENYL)-3,6-DIOXOPIPERAZIN-2-YL]-5,5-DIMETHYL-THIAZOLIDINE-4-CARBOXYLIC ACID (AMOXICILLIN DIKETOPIPERAZINES) AMOXICILLIN TRIHYDRATE IMP. C (EP): (4S)-2-[5-(4-HYDROXYPHENYL)-3,6-DIOXOPIPERAZIN-2-YL]-5,5-DIMETHYL-THIAZOLIDINE-4-CARBOXYLIC ACID (AMOXICILLIN DIKETOPIPERAZINES)
Celecoxib Impurity 2 Celecoxib Impurity 2 948293-46-7 C11H9F3N2
(1-methylpiperidin-4-yl)(pyridin-2-yl)methanone (1-methylpiperidin-4-yl)(pyridin-2-yl)methanone 517875-04-6 C12H16N2O
2-cyano-1,3-bis(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine 2-cyano-1,3-bis(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine 55272-86-1 C16H24N8S2
3-(4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidin-1-yl)propyl 4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate 3-(4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidin-1-yl)propyl 4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate
4-{[(4-carboxybenzyl)amino]methyl}benzoic acid 4-{[(4-carboxybenzyl)amino]methyl}benzoic acid 14900-61-9 C16H15NO4
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(dimethylglycyl)-2,3,4,9-tetrahydro-1H-pyrido [3,4-b]indole-3-carboxylate methyl (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(dimethylglycyl)-2,3,4,9-tetrahydro-1H-pyrido [3,4-b]indole-3-carboxylate methyl 2169996-11-4 C24H25N3O5
Fulvestrant impurity G Fulvestrant impurity G
Canagliflozin Impurity 33 Canagliflozin Impurity 33
2-ethoxy-1-methoxy-4-(2-(methylsulfonyl)ethyl)benzene 2-ethoxy-1-methoxy-4-(2-(methylsulfonyl)ethyl)benzene C12H18O4S
Bendamustine Related Impurity 17 Bendamustine Related Impurity 17
Bortezomib Impurity 24 Bortezomib Impurity 24
Bortezomib Impurity 38 Bortezomib Impurity 38
Edoxaban Impurity 27 Edoxaban Impurity 27
Linagliptin Impurity 30 Linagliptin Impurity 30 2074688-81-4 C33H32N8O5
Pantoprazole Impurity 8 Pantoprazole Impurity 8
Rivaroxaban Impurity 58 Rivaroxaban Impurity 58
Rivaroxaban Impurity 65 Rivaroxaban Impurity 65
Sitafloxacin Impurity 4 Sitafloxacin Impurity 4
Ticagrelor Related Compound 83 Ticagrelor Related Compound 83
Ticagrelor Related Compound 91 Ticagrelor Related Compound 91
Vonoprazan Impurity 21 Vonoprazan Impurity 21
Ceftazidime Oxide Impurity Ceftazidime Oxide Impurity 1301254-48-7 C22H22N6O8S2
N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy)propyl)piperazin-1-yl)acetamide N-(2,6-dimethylphenyl)-2-(4-(2-hydroxy-3-(4-methoxyphenoxy)propyl)piperazin-1-yl)acetamide 1393717-46-8 C24H33N3O4
Atracurium Impurity 2 Atracurium Impurity 2
Blonanserin Impurity J Blonanserin Impurity J
Brexpiprazole Impurity E Brexpiprazole Impurity E
Cefazolin USP Impurity B Cefazolin USP Impurity B
Everolimus Impurity D Everolimus Impurity D
Loratadine Impurity I Loratadine Impurity I 133330-56-0 C22H21ClN2O2
Olaparib Impurity Q Olaparib Impurity Q
Ozagrel Impurity 3 Ozagrel Impurity 3
Pitavastatin Impurity 12 Pitavastatin Impurity 12
Loratadine Impurity 14 Loratadine Impurity 14 169253-13-8 C22H23ClN2O2
Metronidazole Impurity 3 Metronidazole Impurity 3 5006-79-1 C6H7N3O2
Nifedipine Impurity 9 Nifedipine Impurity 9 87625-92-1 C15H15NO5
Peramivir Impurity 7 HCl Peramivir Impurity 7 HCl 1352062-19-1 C14H27ClN2O4
Butylphthalide impurity Butylphthalide impurity 380905-48-6 C12H16O3
Dapoxetine impurity Dapoxetine impurity 2242008-38-2 C30H32ClNO2
Esomeprazole Impurity 26 Esomeprazole Impurity 26 704910-88-3 C15H15N3OS
Pregabalin Impurity 25 Pregabalin Impurity 25
Loxoprofen Loxoprofen 50882-18-3 C7H10O3
Ropivacaine impurity Ropivacaine impurity 1543937-58-1 C13H16N2O3
Mono Oxidation Sugammadex(Org198958-2) Mono Oxidation Sugammadex(Org198958-2) 2412953-13-8 C72H113NaO49S8
3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene) 3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene) C20H26O
2-Hexenoic acid, 2-cyano-5-methyl- 2-Hexenoic acid, 2-cyano-5-methyl- 869-02-3 C8H11NO2
CP-690550A CP-690550A 1243290-37-0 C15H21N5O2
(S)-Tomoxetine (S)-Tomoxetine 105314-53-2 C17H21NO
Fexofenadine EP Impurity F Fexofenadine EP Impurity F 185066-33-5 C31H37NO4
(E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine (E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine 468104-18-9 C13H17NO
4-(5-(pyridin-4-yl)-1H-1,2,4-triazol-3-yl)picolinamide 4-(5-(pyridin-4-yl)-1H-1,2,4-triazol-3-yl)picolinamide 1992028-94-0 C13H10N6O
Indacaterol Impurity 22 Indacaterol Impurity 22 773895-24-2 C31H34N2O3
10-O-2,2-Dichloroethoxycarbonyl Docetaxe 10-O-2,2-Dichloroethoxycarbonyl Docetaxe 158810-73-2 C46H55Cl2NO16
4R,5S)-2,4-diphenyl-4,5-dihydrooxazole-5-carboxylic acid 4R,5S)-2,4-diphenyl-4,5-dihydrooxazole-5-carboxylic acid 849831-77-2 C16H13NO3
ICOFQCJKJOISKD-HSZRJFAPSA-N ICOFQCJKJOISKD-HSZRJFAPSA-N 1435768-96-9 C26H35NO3
DIHYDROCYCLOSPORIN A DIHYDROCYCLOSPORIN A 59865-15-5 C62H113N11O12
Moxidectin Moxidectin 119718-45-5 C37H53NO8
GDZISNMJFAJFMR-BEQCQUFHSA-M GDZISNMJFAJFMR-BEQCQUFHSA-M 2024603-92-5 C58H74N2O15S
GJXNGCFWGJQETE-UHFFFAOYSA-N GJXNGCFWGJQETE-UHFFFAOYSA-N 1796891-27-4 C29H34N6O4
ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate ethyl N-[(2,5-dichlorophenyl)carbonyl]glycinate 328283-61-0 C11H11Cl2NO3
Irbesartan Impurity 4 Irbesartan Impurity 4 945540-26-1 C21H20N6O
BAUCJPGULMYPTE-UHFFFAOYSA-N BAUCJPGULMYPTE-UHFFFAOYSA-N 2097683-67-3 C24H29NO4
Entecavir Impurity 6 Entecavir Impurity 6 1354695-82-1 C26H27N5O3
Bis(L-Valine) Ester Ganciclovir TFA Salt Bis(L-Valine) Ester Ganciclovir TFA Salt 130914-71-5 C19H31N7O6
6-Chloro-6-defluoro Ciprofloxacin 6-Chloro-6-defluoro Ciprofloxacin 93106-58-2 C17H18ClN3O3
5-[(4-amino-2-carboxyphenyl)amino]-2-hydroxybenzoic acid 5-[(4-amino-2-carboxyphenyl)amino]-2-hydroxybenzoic acid 1797983-23-3 C14H12N2O5
4-[1-methoxy-2-(methylamino)ethyl]benzene-1,2-diol:hydrochloride 4-[1-methoxy-2-(methylamino)ethyl]benzene-1,2-diol:hydrochloride 74571-90-7 C10H16ClNO3
(6S,7S)-2-amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-7-ol (6S,7S)-2-amino-6-(propylamino)-4,5,6,7-tetrahydro-1,3-benzothiazol-7-ol
Melphalan EP impurity H Melphalan EP impurity H 88457-23-2 C14H20Cl2N2O2
ethyl 2-(4-(sec-butoxy)-3-formylphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(4-(sec-butoxy)-3-formylphenyl)-4-methylthiazole-5- carboxylate 2375033-31-9 C18H21NO4S
Piperacillin Impurity 4 Piperacillin Impurity 4
(R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one (R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one 2749805-70-5 C16H18F3N5O
Amlodipine Impurity 30 Amlodipine Impurity 30 95574-97-3 C4H7ClO3
Axitinib Impurity 24 Axitinib Impurity 24
Rasagiline Impurity 3 Rasagiline Impurity 3 1175018-74-2 C12H14ClN
(+/-)-EPINEPHRINE SULFONIC ACID (+/-)-EPINEPHRINE SULFONIC ACID 26405-77-6 C9H13NO5S
GADOTERIDOL   RELATED  COMPOUND   B  (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) GADOTERIDOL RELATED COMPOUND B (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) 112188-16-6 C14H22GdN4O6
4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide 150727-06-3 C25H24ClN5O4S
(S)-2-(BENZYLOXY)PROPIONAL (S)-2-(BENZYLOXY)PROPIONAL 81445-44-5 C10H12O2
1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene 1662702-90-0 C15H15ClO
Mupirocin iMpurity F Mupirocin iMpurity F C26H44O9
Palbociclib Impurity 87 Palbociclib Impurity 87 571189-51-0 C25H31N7O2
Beclometasone Impurity U Beclometasone Impurity U
Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) Atracurium Impurity 15 Iodide(Cisatracurium Besilate EP Impurity O Iodide) 155913-31-8 C38H49NO11S
Vortioxetine Impurity 29 Vortioxetine Impurity 29 1928741-88-1 C18H23ClN2S
Neratinib Impurity 12 Neratinib Impurity 12 544417-27-8 C33H37ClN6O3
Ceftriaxone Sodium impurity 2 Ceftriaxone Sodium impurity 2
Elagolix Sodium impurity4 Elagolix Sodium impurity4 2248628-92-2 C19H21NO4S
Tadalafil Impurity 45 Tadalafil Impurity 45
(R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol (R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol C28H28O3
(trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
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