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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
Vildagliptin Impurity ZA6 Vildagliptin Impurity ZA6 2246354-69-6 C17H23N3O2
Nintedanib Impurity O Nintedanib Impurity O
Palonosetron Impurity TM1-SS Palonosetron Impurity TM1-SS 1260610-96-5 C15H23ClN2
Amoxicillin EP impurity P Amoxicillin EP impurity P C16H19N3O5S
Amoxicillin EP impurity P Amoxicillin EP impurity P C16H19N3O5S
Eltrombopag Impurity 3 Eltrombopag Impurity 3
Saxagliptin Impurity 5 (Epoxy saxaglliptin) Saxagliptin Impurity 5 (Epoxy saxaglliptin)
(1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride (1r,4r)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride 101900-44-1 C13H20BrClN2O
(41S,12S,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid (41S,12S,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid 59413-21-7 C20H25N2NaO3
BDJS-SH 1 BDJS-SH 1 36588-45-1 C12H18N2O2
Acyclovir Impurity O Acyclovir Impurity O
Alogliptin Impurity 19 Alogliptin Impurity 19
Alogliptin Impurity 19 Alogliptin Impurity 19
Aprepitant Impurity 17 Aprepitant Impurity 17 1333998-27-8 C20H19ClF7NO2
Blonanserin impurity A Blonanserin impurity A
Captopril impurity 2 Captopril impurity 2
Ciprofloxacin Impurity D HCl Ciprofloxacin Impurity D HCl 526204-10-4 C17H18FN3O3
Clindamycin Impurity 6 Clindamycin Impurity 6
Dabigatran Impurity 5 Dabigatran Impurity 5
DecitaBine Impurity 10 DecitaBine Impurity 10
Empagliflozin Impurity 17 Empagliflozin Impurity 17 2452301-27-6 C23H28O7
Erlotinib Impurity 31 Erlotinib Impurity 31
Everolimus impurity C Everolimus impurity C
Ezetimibe Impurity 28 Ezetimibe Impurity 28
FeBuxostat Impurity 30 FeBuxostat Impurity 30
Fluconazole Impurity 5 Fluconazole Impurity 5 94952-36-0 C14H14F2N6O
Fosaprepitant Impurity 2 Fosaprepitant Impurity 2
Imidafenacin Impurity 4 Imidafenacin Impurity 4 503598-78-5 C16H18N2O
Intedanib Impurity H Intedanib Impurity H
Isavuconazole Impurity 16 Isavuconazole Impurity 16
Isavuconazole Impurity 4 Isavuconazole Impurity 4
Lenvatinib Impurity 4 Lenvatinib Impurity 4 C28H22ClN5O5
Linagliptin Impurity 45 Linagliptin Impurity 45
MiraBegron Impurity F MiraBegron Impurity F
Moxifloxacin Impurity 19 Moxifloxacin Impurity 19
Moxifloxacin Impurity 34 Moxifloxacin Impurity 34 1824286-08-9 C9H7ClF2O3
Nifedipine Impurity J Nifedipine Impurity J 114709-68-1 C16H17N3O5
Oxiracetam Impurity I Oxiracetam Impurity I 142274-07-5 C7H9NO4
PalBociclib Impurity 4 PalBociclib Impurity 4
Plerixafor Impurity 4 Plerixafor Impurity 4
Posaconazole Impurity 29 Posaconazole Impurity 29
Posaconazole Impurity 34 Posaconazole Impurity 34
Posaconazole Impurity 58 Posaconazole Impurity 58
Pregabalin Impurity 4 Pregabalin Impurity 4 1955498-14-2 C10H22ClNO2
Rabeprazole Impurity 17 Rabeprazole Impurity 17
SofosBuvir Impurity 14 SofosBuvir Impurity 14
sofosBuvir Impurity 34 sofosBuvir Impurity 34
SofosBuvir Impurity 50 SofosBuvir Impurity 50
SofosBuvir Impurity 56 SofosBuvir Impurity 56
Tofacitinib impurity T Tofacitinib impurity T 1092578-43-2 C16H20N6O
Valsartan Impurity 39 Valsartan Impurity 39 C24H29N5O3
(1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)cyclopropanecarboxylic acid (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)cyclopropanecarboxylic acid 1369769-35-6 C17H17FN2O3
Donepezil  Impurity Donepezil Impurity 844694-84-4 C24H31NO2
imp.E imp.E 950781-89-2 C13H12F3N3O3
Disalicylimide Disalicylimide 1972-71-0 C14H11NO4
Diltiazem impurity Diltiazem impurity 115992-91-1 C17H18N2O3S
Raloxifene EP IMpurity Raloxifene EP IMpurity 1700655-64-6 C13H15ClN2O2S
Parecoxib Impurity M Parecoxib Impurity M
(-)-Lyoniresinol 9'-O-glucoside (-)-Lyoniresinol 9'-O-glucoside 143236-02-6 C28H38O13
Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- Cycloocta[b]pyridine, 2-(4-ethyl-1-piperazinyl)-4-[4-(4-ethyl-1-piperazinyl)phenyl]-5,6,7,8,9,10-hexahydro- 1648791-23-4 C29H43N5
Linagliptin Impurity O Linagliptin Impurity O
Linagliptin Impurity T Linagliptin Impurity T
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzamide C18H22FN5O3
Apremilast Impurity 2 Apremilast Impurity 2
Etoricoxib Impurity 16 Etoricoxib Impurity 16
Ibrutinib Impurity 2 Ibrutinib Impurity 2 2417548-78-6
Mirabegron Impurity 14 Mirabegron Impurity 14
Vonoprazan Impurity 1 Vonoprazan Impurity 1 881732-90-7 C17H17N3O2S
Atenolol EP Impurity Atenolol EP Impurity C14H22N2O3
Cinacalcet Impurity 20 Cinacalcet Impurity 20
Dapagliflozin Impurity 11 Dapagliflozin Impurity 11
Dasatinib Impurity C Dasatinib Impurity C
1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1-(7,8-dihydronaphthalen-1-yl)ethan-1-amine hydrochloride 1822601-94-4 C12H15N
Sofosbuvir metabolites Sofosbuvir metabolites 1859162-80-3 C16H18FN2O8P
1,3,5,7-tetrahydroxyadamantane 1,3,5,7-tetrahydroxyadamantane 16104-28-2 C10H16O4
Cabozantinib Impurity E Cabozantinib Impurity E
Loxoprofen Impurity I Loxoprofen Impurity I
Sofosbuvir Impurity22 Sofosbuvir Impurity22
Donepezil Impurity-OH Donepezil Impurity-OH 148517-82-2 C11H12O4
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-(hydroxyamino)pyrimidin-2-one 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-(hydroxyamino)pyrimidin-2-one 13491-41-3 C9H13N3O6
Lidocaine EP Impurity Lidocaine EP Impurity 31785-64-5 C12H18N2O.ClH
Prucalopride Impurity 1 Prucalopride Impurity 1 1900715-96-9 C18H24ClN3O3
3-(5-CHLOROPYRID-2-YL)CARBAMOYLPYRAZINE-2-CARBOXYLIC ACID(WXG01564) 3-(5-CHLOROPYRID-2-YL)CARBAMOYLPYRAZINE-2-CARBOXYLIC ACID(WXG01564) 43200-83-5 C11H7ClN4O3
Ampicillin Impurity Q Ampicillin Impurity Q
Cefdinir Impurity  PQ(CP) Cefdinir Impurity PQ(CP)
Cefdinir Impurity IJKL Cefdinir Impurity IJKL
Ceftazidime Impurity A (EP) Ceftazidime Impurity A (EP)
Oxacillin Sodium Impurity E(EP) Oxacillin Sodium Impurity E(EP)
Spectinomycin Impurity B Spectinomycin Impurity B
Eriodictyol-8-glucoside Eriodictyol-8-glucoside 153733-96-1 C21H22O11
Naringin 4'-glucoside Naringin 4'-glucoside 17257-21-5 C33H42O19
8-(benzo[b]thiophen-4-yl)-5,8-diazaspiro[4.5]decan-5-ium chloride 8-(benzo[b]thiophen-4-yl)-5,8-diazaspiro[4.5]decan-5-ium chloride 2143944-64-1 C16H21N2S+
2-(4'-chloro-2,3,4,5-tetrahydro-[1,1'-biphenyl]-4-yl)-3-hydroxynaphthalene-1,4-dione 2-(4'-chloro-2,3,4,5-tetrahydro-[1,1'-biphenyl]-4-yl)-3-hydroxynaphthalene-1,4-dione 1809464-27-4 C22H17ClO3
Aprepitant impurity C Aprepitant impurity C
Ticagrelor Related Compound 14 Ticagrelor Related Compound 14 2056269-94-2 C23H28F2N6O4S
Cefoxitin impurity E Cefoxitin impurity E 2395025-32-6 C17H19N3O8S2
N-((4-(3-methyl-5-phenylisoxazol-4-yl)phenyl)sulfonyl)propionamide N-((4-(3-methyl-5-phenylisoxazol-4-yl)phenyl)sulfonyl)propionamide 477594-28-8 C19H18N2O4S
Moxifloxacin EP Impurity D HCl Moxifloxacin EP Impurity D HCl
Moxifloxacin Impurity 30 Moxifloxacin Impurity 30 1395056-42-4 C21H24FN3O7
Tenofovir Impurity 37 Tenofovir Impurity 37 161760-03-8 C10H15O6PS
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