DDC Mass Spect Gold®
Human Serum, Ultra-low Hormones, Steroids and other Analytes for Immunoassays and LCMS Applications
Catalog Number: MSG3000
Source: Human Plasma Defibrinated
Storage: -20°C
Common Uses:
  • Base matrix for Hormone and Steroid calibrators, controls, standards and linearity products
  • Hormone and Steroid Mass Spectrometry applications
Contact us or 888-690-0963
Order:
Catalog NumberUnitPriceQty
MSG3000 100ml   
MSG3000 300ml   
MSG3000 1L   
Please contact us to discuss your specific requirements or volume discounts.
Product Information:
DDC Mass Spect Gold® is processed from human plasma using a validated process that reduces the hormone and steroid levels, please see average hormone and steroid values below. This process also maintains the inherent characteristics of the human plasma resulting a in a pool that is consistent with patient samples. The human plasma is collected from donors at FDA licensed facilities. Each donor is screened for donor eligibility according to FDA regulations. Each unit is tested for and found negative for HIV1/2-ab, HBsAg, HCV-ab, HIV-1 (NAT), HCV (NAT) and RPR. The plasma is inspected for conformance to raw material specifications. The plasma is processed according to a batch record. The finished product is analyzed and inspected according to quality control procedures for conformance to specifications. Records from donor unit(s) to final product are maintained according to established procedures. These records include donor records, raw material inspection records, batch records, testing records (baseline through final product), labeling records, final product inspection records and batch release records.

Product Specifications:
This product is processed to Golden West Biologicals, Inc.® specifications listed below or can be processed to specific customer requirements.
Contact us to discuss your specific requirements.

Golden West Biologicals, Inc.® Specifications

Analyte RangeTypicalUOM Analyte RangeTypicalUOM
Sodium 131-151 139 mmol/L Testosterone
(LCMS)
<2.5 <2.5 ng/dl
Chloride 85 - 108 95 mmol/L Testosterone
(Immunoassay)
<0.026 <0.026 ng/ml
Potassium 3.5 - 5.5 4.3 mmol/L Cortisol
(Immunoassay)
<0.2 <0.2 µg/dl
Calcium 5.0 - 10.0 8.6 mg/dl HCG
(Immunoassay)
<2.0 <2.0 mIU/ml
Total Protein 4.8 - 5.2 5.0 g/dl LH
(Immunoassay)
<0.07 <0.07 mIU/ml
Cholesterol <10 <10 mg/dl 17-Hydroxypregnenolone
(LCMS)
<10
As Tested*
<10 ng/dl
Albumin 3.0 - 3.8 3.6 g/dl Dihydrotestosterone
(DHT)(LCMS)
<10
As Tested*
<10 ng/ml
Glucose 65 - 105 81 mg/dl 11 – Deoxycortisol
(LCMS)
<1
As Tested*
<1 ng/dl
Triglycerides <10 <4 mg/dl Deoxycorticosterone
(LCMS)
<2
As Tested*
<2 ng/ml
T4 (Immunoassay) <0.3 <0.3 µg/dl 18 - Hydroxycorticosterone
(LCMS)
<5
As Tested*
<5 ng/dl
TSH 3rd Generation (Immunoassay) <0.05 <0.004 µIU/ml Corticosterone
(LCMS)
<10
As Tested*
<10 ng/ml
Progesterone (Immunoassay) <0.105 <0.100 ng/dl Catecholamines
(LCMS)
Negative
As Tested*
Negative  
Free Estradiol (LCMS) <0.03 <0.03 pg/dl Filtration 0.1 µm 0.1 µm  
Estradiol (LCMS) <1.0 <1.0 pg/dl Preservative None** None  
Estradiol (Immunoassay) <10 <10 pg/dl pH 7.0 - 7.5 7.2  
Androstenedione (LCMS) <10
As Test*
<10 ng/dl Microbial <10 <1 cfu/ml
*These results are typical of the product but are not a specification for release of a lot

Toxicology Testing*
d-metheamphetamine None Detected Pentobarbital None Detected
d, l-amphetamine None Detected Phenobarbital None Detected
Amobarbital None Detected Secobarbital None Detected
Butabital None Detected Ethanol None Detected
Codeine None Detected Oxazepam None Detected
Proproxyphene None Detected 6-Mono-Acetylmorphine None Detected
Nordiazepam None Detected MDMA None Detected
Delta-9-THC None Detected Nitrazepam None Detected
Delta-9-THC-COOH None Detected EDDP None Detected
Benzoylecgonine None Detected LSD None Detected
Methadone None Detected Phencyclidine None Detected
Methaqualone None Detected Morphine None Detected
Morphine 3-β-d-glucuronide None Detected    

*These results are typical of the product but are not a specification for release of a lot


Each unit of plasma used in the preparation of this material was testedand found negative for HIV 1/2-ab, HBsAg, HCV-ab, HIV-1 (NAT), HCV (NAT) and RPR by FDA approved methods.

Not for use in humans or clinical diagnosis. This product is intended for further manufacturing and/or research applications.

**Preservatives can be added upon customer request.
Customer specific requirements for specifications, gender, processing, filling, and testing can be met upon request.

Standard fill volumes: 100ml, 300ml, 1 Liter
Custom fill volumes are available upon request.